Abstract：
BACKGROUND: In 2022 and 2023, Medtronic recalled implantable defibrillators because they may deliver less than full-energy shocks. The 2022 problem truncates the second phase of the waveform (SCP-T2), resulting in ∼32-J shocks, and is mitigated by downloadable software. The 2023 malfunction truncates the first phase of the waveform, resulting in 0- to 12-J shocks due to a glassed feedthrough problem (GFT-T1) that might be avoided by programming B>AX shock polarity.
OBJECTIVE: The purpose of this study was to assess the consequences of GFT-T1 and SCP-T2 shocks in the Food and Drug Administration\'s Manufacturers and User Facility Device Experience (MAUDE) database and to estimate the incidences of GFT-T1 and SCP-T2.
METHODS: We analyzed MAUDE reports supplemented by Medtronic data; lead failures were excluded. The incidences of SCP-T2 and GFT-T1 were estimated using USA volumes for devices with glassed feedthroughs.
RESULTS: One hundred thirty-two devices delivered truncated shocks: 27 (20.5%) were GFT-T1; 103 (78.0%) were SCP-T2; and 2 (1.5%) truncated both phases (BOTH-T1&2). Of 54 ventricular fibrillation (VF) patients, 21 (38.9%) were not defibrillated by truncated shocks: 8 (38.1%) received GFT-T1 shocks, 12 (57.1%) received SCP-T2 shocks, and 1 received a BOTH-T1&2 shock; 2 patients suffered unrelated deaths; 1 was externally rescued; 1 outcome was unknown; the others were defibrillated by subsequent shocks or terminated spontaneously. The majority of patients (79.1%) shocked for ventricular tachycardia (VT) were converted, primarily (94.1%) by SCP-T2 shocks. Estimated incidences of GFT-T1 and SCP-T2 were 0.0078%-0.0088% and 0.1062%-0.1110%.
CONCLUSIONS: GFT-T1 and SCP-T2 shocks can result in failure to terminate VF/VT, but they may be preventable. Although the incidences of these truncated shocks are very low, heightened surveillance is warranted.
OBJECTIVE: The purpose of this study was to assess the consequences of GFT-T1 and SCP-T2 shocks in the Food and Drug Administration\'s Manufacturers and User Facility Device Experience (MAUDE) database and to estimate the incidences of GFT-T1 and SCP-T2.
METHODS: We analyzed MAUDE reports supplemented by Medtronic data; lead failures were excluded. The incidences of SCP-T2 and GFT-T1 were estimated using USA volumes for devices with glassed feedthroughs.
RESULTS: One hundred thirty-two devices delivered truncated shocks: 27 (20.5%) were GFT-T1; 103 (78.0%) were SCP-T2; and 2 (1.5%) truncated both phases (BOTH-T1&2). Of 54 ventricular fibrillation (VF) patients, 21 (38.9%) were not defibrillated by truncated shocks: 8 (38.1%) received GFT-T1 shocks, 12 (57.1%) received SCP-T2 shocks, and 1 received a BOTH-T1&2 shock; 2 patients suffered unrelated deaths; 1 was externally rescued; 1 outcome was unknown; the others were defibrillated by subsequent shocks or terminated spontaneously. The majority of patients (79.1%) shocked for ventricular tachycardia (VT) were converted, primarily (94.1%) by SCP-T2 shocks. Estimated incidences of GFT-T1 and SCP-T2 were 0.0078%-0.0088% and 0.1062%-0.1110%.
CONCLUSIONS: GFT-T1 and SCP-T2 shocks can result in failure to terminate VF/VT, but they may be preventable. Although the incidences of these truncated shocks are very low, heightened surveillance is warranted.
摘要：
背景：在2022年和2023年，Medtronic召回了植入式除颤器，因为它们可能会提供少于全能量的电击。2022问题截断了波形的第二阶段（SCP-T2），导致32J冲击，并通过可下载软件缓解；2023年故障截断了波形的第一阶段，由于玻璃馈通问题（GFT-T1）导致0-12J冲击，这可以通过编程B>AX冲击极性来避免。
目的：1）评估FDAMAUDE数据库中GFT-T1和SCP-T2电击的后果；2）估计GFT-T1和SCP-T2的发生率。
方法：我们分析了由Medtronic数据补充的MAUDE报告；排除了导线故障。SCP-T2和GFT-T1的发生率是使用美国卷对带有玻璃馈通的设备进行估算的。
结果：132个装置提供了截短的电击：27个（20.5%）为GFT-T1；103个（78.0%）为SCP-T2；2个（1.5%）截短了两个阶段（两者-T1&2）。在54例VF患者中，21例（38.9%）未通过截断电击除颤：8例（38.1%）接受GFT-T1电击，12例（57.1%）接受了SCP-T2电击，1例同时接受了T1&2电击；2例患者无关联死亡；1例外部抢救；1例结果不详；其他患者通过随后的电击进行除颤或自发终止。大多数因室性心动过速而休克的患者（79.1%）均被转换，主要（94.1%）被SCP-T2电击。GFT-T1和SCP-T2的估计发生率为0.0078-0.0088%和0.1062-0.1110%。
结论：GFT-T1和SCP-T2电击可能导致VF/VT无法终止，但可以预防。虽然这些截断冲击的发生率非常低，加强监视是必要的。
目的：1）评估FDAMAUDE数据库中GFT-T1和SCP-T2电击的后果；2）估计GFT-T1和SCP-T2的发生率。
方法：我们分析了由Medtronic数据补充的MAUDE报告；排除了导线故障。SCP-T2和GFT-T1的发生率是使用美国卷对带有玻璃馈通的设备进行估算的。
结果：132个装置提供了截短的电击：27个（20.5%）为GFT-T1；103个（78.0%）为SCP-T2；2个（1.5%）截短了两个阶段（两者-T1&2）。在54例VF患者中，21例（38.9%）未通过截断电击除颤：8例（38.1%）接受GFT-T1电击，12例（57.1%）接受了SCP-T2电击，1例同时接受了T1&2电击；2例患者无关联死亡；1例外部抢救；1例结果不详；其他患者通过随后的电击进行除颤或自发终止。大多数因室性心动过速而休克的患者（79.1%）均被转换，主要（94.1%）被SCP-T2电击。GFT-T1和SCP-T2的估计发生率为0.0078-0.0088%和0.1062-0.1110%。
结论：GFT-T1和SCP-T2电击可能导致VF/VT无法终止，但可以预防。虽然这些截断冲击的发生率非常低，加强监视是必要的。
