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

Model Number 5076

Device Problems Premature Discharge of Battery (1057); High impedance (1291); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this pacemaker device exhibited a subsequent high out of range pace impedance measurement on the right ventricular (rv) lead which triggered a lead safety switch (lss).As a result, the pacemaker device automatically switches the rv lead from the bipolar to the unipolar pace and sense configuration.The rv lead is not a boston scientific product.The patient was noted to be in the clinic for lss testing ahead of a scheduled device replacement procedure for premature battery depletion.It was indicated that after the high out of range impedance measurement, the impedance had returned back to within normal specification limits.There was no noise observed or able to be reproduced with isometric testing, but higher impedance measurements were observed during this testing.The impedance measurement in the bipolar configuration was noted to be 387 ohms and during the isometric testing, it was 2000 ohms.The rv threshold measurement in the unipolar configuration was noted to be 0.5 volts at 0.4 ms, which is appropriate.The rv threshold was not measured in the bipolar configuration.Boston scientific technical services (ts) explained to the boston scientific representative that this high impedance measurement may be due to a device header spring contact issue based on the fact that noise could not be reproduced.Evidence is suggestive that the pacemaker device was subsequently explanted as scheduled and replaced with a different manufacturer's device, and the rv lead remains in-service.No additional 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: 17528731
• MDR Text Key: 321445384
• Report Number: MW5135660
• 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: 09/23/2021

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
• Patient Sequence Number: 1