MAUDE Adverse Event Report: UNKNOWN VITATRON; PERMANENT PACEMAKER ELECTRODE

Model Number R16Q

Device Problems High Sensing Threshold (2574); No Pacing (3268)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported that this right ventricular (rv) lead was an attempted implant.When connecting the lead to the device after being inserted into the pocket, testing was performed in which there was lack of pacing with bipolar and high threshold measurements in unipolar.A different rv lead was implanted and remains in service.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: VITATRON
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17536993
• MDR Text Key: 321403580
• Report Number: MW5143876
• Device Sequence Number: 1
• Product Code: DTB
• 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: 06/03/2022

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: R16Q
• Device Lot Number: VLTATRON
• Patient Sequence Number: 1