FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 3993948
·
Received August 8, 2014
Report
- Report Number
- 3008973940-2014-00298
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 29, 2014
- Report Date
- June 29, 2014
- Manufacturer
- MEDTRONIC SINGAPORE OPERATIONS
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
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 THAT THE DEVICE WAS IMPLANTED TWO DAYS POST EXPIRATION DATE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468926 | ADAPTA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC SINGAPORE OPERATIONS | ADDRS1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00089 YR |