Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
FDA adverse event reports and recall history for generator, pulse, pacemaker, external programmable (for electrophysiological studies only) (product code JOQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 148
- Deaths
- 2
- Injuries
- 46
- Malfunctions
- 72
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2009-06-12TerminatedDevice Design
EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP MedSystems, Inc. 575 Route 73 North, Units D, West Berlin, NJ 08091. Indicated for use during clinical electrophysiology procedures.
Non-compliance with IEC Standard 60601-1 Clause 57.6 relative to fusing of AC input line. The neutral line is not fused. The hot line in fused. Clause 57.6 calls for both lines to be fused.
- 2006-05-31TerminatedOther
EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator. The stimulator is capable of single channel, simultaneous and sequential stimulation at programmed output settings using built-in protocols, and includes an emergency stimulation function.
Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or RF ablation unit-2)-Presence of a DC offset voltage on an output channel-3)-Inability to synchronize with a non-EP MedSystems recording system
- 2005-04-19TerminatedOther
Bloom DTU-215-B Programmable Stimulator
Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
Monitor generator, pulse, pacemaker, external programmable (for electrophysiological studies only) automatically
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