NA 5487Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169307339), received between Aug 7, 2018 and Oct 29, 2020 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2020Failure to Capture; Material Integrity Problem; Failure to Capture; Material Integrity Problem

  IT WAS REPORTED THAT WHEN USING A PACING CABLE IT SHOWED SIGNS OF NO CAPTURE AND WAS UNRELIABLE AFTER TWO MINUTES OF USE. THE LEAD WAS CONNECTED TO AN EXTERNAL CARDIAC DEVICE INSTEAD TO OBTAIN A MORE RELIABLE CONNECTION. THE PACING CABLE WAS DISCARDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10753766 ↗
• InjuryOct 13, 2020Failure to Capture; Material Integrity Problem; Failure to Capture; Material Integrity Problem

  IT WAS REPORTED THAT WHEN USING THE PACING CABLES WITH AN EXTERNAL PULSE GENERATOR THERE WAS NO CAPTURE WHEN THE LEAD WAS CONNECTED INTO THE CABLE HEAD. IT WAS NOTED THAT AN EXPLANTED DEVICE THAT CONNECTED DIRECTLY VIA IS-1 PORT AND LEFT EXTERNAL WAS THEN USED INSTEAD OF THE EXTERNAL PULSE GENERATOR TO RESOLVE THE ISSUE. THE PACING CABLES WERE DISCARDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670337 ↗
• InjuryOct 13, 2020Failure to Capture; Material Integrity Problem; Failure to Capture; Material Integrity Problem

  IT WAS REPORTED THAT WHEN USING THE PACING CABLES WITH AN EXTERNAL PULSE GENERATOR THERE WAS NO CAPTURE WHEN THE LEAD WAS CONNECTED INTO THE CABLE HEAD. IT WAS NOTED THAT AN EXPLANTED DEVICE THAT CONNECTED DIRECTLY VIA IS-1 PORT AND LEFT EXTERNAL WAS THEN USED INSTEAD OF THE EXTERNAL PULSE GENERATOR TO RESOLVE THE ISSUE. THE PACING CABLES WERE DISCARDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670331 ↗
• InjurySep 18, 2020Capturing Problem; Material Integrity Problem; Capturing Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, TWO DAYS AFTER A PATIENT WAS GIVEN A TEMPORARY EXTERNAL PACER, THE CABLES DID NOT WORK AS PACING FROM THE EXTERNAL TEMPORARY PACER DID NOT OCCUR. IT WAS NOTED THAT WHILST TESTING THE LEAD WITH ALLIGATOR CLIP CABLES TO A PROGRAMMER, THE IMPEDANCE AND THRESHOLD READINGS WERE NORMAL HOWEVER WHEN CONNECTING THESE CABLES, THE PATIENT EXPERIENCED ASYSTOLE. THE EXTERNAL TEMPORARY PACER WAS AT MAX OUTPUT AT 100 BEATS PER MINUTE (BPM) ALTHOUGH THERE WAS NO CAPTURE. THE CABLE WAS CHANGED OUT FOR AN ALTERNATIVE CABLE FROM THE SAME LOT WHICH GAVE THE SAME RESULT. A DIFFERENT EXTERNAL TEMPORARY PACER WITH A SECOND SET OF WIRES WAS USED AND STILL SHOWED NO CAPTURE. IN THE EVENT THE LEAD THAT WAS PREVIOUSLY IMPLANTED WAS USED TO CONTINUE TO PACE THE UNIT UNTIL THE CLINICIAN WAS READY TO IMPLANT ON THE OTHER SIDE. THE CABLES HAVE BEEN DISCARDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 10552689 ↗
• MalfunctionJul 6, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE DISPOSABLE TEMPORARY PACING LEAD FAILED TO PACE THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10233065 ↗
• InjuryAug 7, 2018Failure to Capture; Over-Sensing; Connection Problem; Material Integrity Problem; Over-Sensing; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT, WHILE BEING PACED WITH AN EXTERNAL PULSE GENERATOR (EPG) DURING A DEVICE REPLACEMENT PROCEDURE, THE PATIENT WENT INTO ASYSTOLE, WITH LOSS OF CAPTURE AND OVERSENSING EXHIBITED. IT WAS NOTED THAT THE ISSUE AROSE WHEN THE REPLACEMENT LEAD AND PATIENT CABLE WERE BEING TAPED DOWN. THE PATIENT WAS PACED WITH AN EXTERNAL DEFIBRILLATOR AND THE CONNECTION BETWEEN THE PATIENT CABLE AND LEAD WAS ADJUSTED, BUT THE ISSUE PERSISTED. THE LEAD WAS CONNECTED TO A PACING ANALYZER AND SHOWN TO FUNCTION NORMALLY. THE PATIENT CABLE WAS REPLACED, AND THE PATIENT WAS ABLE TO BE PACED WITH THE EPG AND LEAD WITHOUT ISSUE. IT WAS NOTED THAT THE IMPLANTING PHYSICIAN ATTRIBUTED THE ISSUE TO THE CONNECTOR BLOCK OF THE PATIENT CABLE. THE CABLE WAS RETURNED FOR ANALYSIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 7756658 ↗