MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5392

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2023

Event Type  malfunction  

Event Description

Patient is pacemaker dependent because of complete heart block and low intrinsic heart rate (he is currently awaiting permanent pacemaker placement).While caring for the patient, it was noticed that battery of pacemaker being used was half-full and required immediate changing.However, the button on the bottom was malfunctioning and unable to pop open to allow for a quick battery change.Therefore, it was required for a complete change to a new pacemaker.Attending and physician assistant (pa) at bedside for the change to the new pacemaker due to the high risk of the procedure.It was noted during this, that when placed on the original pacemaker, that the pacing wires had been wrapped and tied multiple times around the hook at the top, which made this very difficult because the doctor had to untie and untangle the pacing wires in an emergent situation.A recommendation going forward would be to standardize practice so that no pacing wires are ever knotted/wrapped around the pacemaker in such a way and it makes changing pacemakers difficult.Pacemaker djh046493p, model 5392.Faulty pacemaker red-tagged and removed from use.Biomed update: found unit during rounds with red tag indicating "battery won't come out." checked unit's condition, found battery tray slightly jammed and was able to free it.Was able install and eject tray number of times.Returned to service.

• Brand Name: MEDTRONIC
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 18354525
• MDR Text Key: 330871695
• Report Number: 18354525
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5392
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2023
• Date Report to Manufacturer: 12/19/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7300 DA
• Patient Sex: Male