FDA Adverse Event
Malfunction
Summary report: N
ADAPTA SR
MDR report key: 1922273
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-05906
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CARELINK REPORT FOR THIS DEVICE SHOWS THE SERIAL NUMBER AS ALL ZEROS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2010 AND THERE WAS NO PROBLEM WITH THE DEVICE AND REPROGRAMMING WAS NOT NECESSARY. 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 |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA SR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADSR03 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | 4012 IMPLANTABLE PACING LEAD |