FDA Adverse Event
Malfunction
Summary report: N
LEAD
MDR report key: 16869802
·
Received May 4, 2023
Report
- Report Number
- 2017865-2023-19134
- Event Type
- Malfunction
- Date Received
- May 4, 2023
- Date of Event
- April 14, 2023
- Report Date
- August 30, 2023
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CORRECTED INFORMATION: SECTION D2B PROCODE SHOULD BE "NVN." THE PREVIOUS REPORT WAS INCORRECTLY SUBMITTED AS "NWM."
Description of Event or Problem · 0
RELATED MANUFACTURE REFERENCE NUMBER: 2017865-2023-19133. IT WAS REPORTED THAT THE PATIENT'S LEAD WAS DISCONNECTED FROM HIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO INTERVENTIONS WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 811484 | LEAD | PERMANENT PACING ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | LEAD | ||
| 956371 | LEAD | PERMANENT PACING ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | LEAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male |