MAUDE Adverse Event Report: OSCOR UNKNOWN; PERMANENT PACEMAKER ELECTRODE

Model Number RX58TSBV

Device Problem High Sensing Threshold (2574)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2011

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 1996 and was capped on (b)(6) 2011 due to high thresholds.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): OSCOR
• MDR Report Key: 17527947
• MDR Text Key: 321415495
• Report Number: MW5134878
• 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: 11/03/2011

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: RX58TSBV
• Patient Sequence Number: 1