MalfunctionNHW
LEAD
Received Mar 6, 2023 · Event occurred Mar 2, 2023
Report 2017865-2023-11916 · MDR key 16490463
Device
Generic name
Permanent Pacing Electrode
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
LEADProduct problems
- Defective Device
- Defective Device
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE LEAD WAS RETURNED WITH NO REPORTED EVENT. FAILURE EVENT OBSERVED DURING ANALYSIS. AS RECEIVED, A PARTIAL LEAD WAS RETURNED IN ONE PIECE. VISUAL EXAMINATION FOUND AN EXTERNAL ABRASION BREACHING THE OUTER INSULATION CONSISTENT WITH FRICTION TO ANOTHER DEVICE OR FEATURE OF THE PATIENT ANATOMY. NO OTHER ANOMALIES WERE IDENTIFIED.
Description of Event or Problem
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.