MAUDE Adverse Event Report: BIOTRONIK PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number ST53

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2011

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2007 and capped on (b)(6) 2011 due to non-capture and high threshold.The physician was dr.(b)(6) at (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17535299
• MDR Text Key: 321177516
• Report Number: MW5142198
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 05/04/2011

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: ST53
• Patient Sequence Number: 1