MAUDE Adverse Event Report: MEDTRONIC DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 5076

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Pacing Intermittently (1443); Impedance Problem (2950)

Patient Problems Failure of Implant (1924); Asystole (4442)

Event Type  Injury  

Event Description

It was reported that the pacemaker system exhibited high impedances out of range on this non boston scientific right ventricular (rv) lead, subsequently the lead was reprogrammed to unipolar and the measurements were stable.Then, six months later, the rv lead exhibited loss of capture, high impedances out of range, and low impedances within normal limits when reprogrammed.Technical services (ts) reviewed data, and found noisy signals and pacing inhibition with asystole of more than two seconds.Ts suspected the cause was a lead integrity issue.This pacemaker system remains in service and the physician plans to replaced the rv lead.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17536879
• MDR Text Key: 321152727
• Report Number: MW5143762
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 5076
• Device Lot Number: PJN4580347
• Patient Sequence Number: 1