%0 Journal Article
%T Failure to defibrillate or cardiovert due to premature truncation of biphasic shocks from implantable defibrillators.
%A Hauser RG
%A Kapphahn-Bergs M
%A Casey SA
%A Witt DR
%A Sengupta JD
%J Heart Rhythm
%V 21
%N 2
%D 2024 Feb 11
%M 37956776
%F 6.779
%R 10.1016/j.hrthm.2023.11.006
%X <B>BACKGROUND: </B>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.<BR><B>OBJECTIVE: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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%.<BR><B>CONCLUSIONS: </B>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.