MAUDE Adverse Event Report: MEDTRONIC, INC. RV LEAD; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 5076

Device Problems Failure to Capture (1081); Pacing Intermittently (1443)

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

Event Type  Injury  

Event Description

It was reported during a routine device revision procedure that the pacemaker device and this right ventricular (rv) lead exhibited failure to capture and asystole for greater than 2 seconds, during thresholds testing (0.6v@0.4ms).Thresholds testing was re-attempted, post pocket closure and correctly identified thresholds at 0.7v @ 0.3ms.All other measurements were within normal range.Device remains implanted.Besides surgical intervention, no adverse patient effects were observed.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 17365345
• MDR Text Key: 319525816
• Report Number: MW5119728
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5076
• Device Lot Number: 2032335
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1