FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC.SIGMA
MDR report key: 3152702
·
Received June 7, 2013
Report
- Report Number
- 9614453-2013-01220
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Report Date
- April 15, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE HAD NO TELEMETRY. BATTERY END OF LIFE WAS HIGHLY SUSPECTED. ACCORDING TO HOSPITAL RECORDS THE LAST DEVICE CHECK WAS APPROXIMATELY THREE YEARS PRIOR. THE PATIENT DID NOT NOTICE ANY SYMPTOMS. THE DEVICE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253234 | MEDTRONIC.SIGMA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | SSR303B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00084 YR | 5554 IMPLANTABLE PACING LEAD |