FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 2810923
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06058
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- Z-2120-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
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 THE PATIENT HAD BEEN HAVING EVENTS OF LIGHTHEADEDNESS AND HAD ALMOST PASSED OUT. FOLLOW UP WAS ATTEMPTED, BUT NO PRODUCT PERFORMANCE INFORMATION WAS AVAILABLE AS THE PATIENT HAS NOT BEEN SEEN BY THE PHYSICIAN. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other | 5534 IMPLANTABLE PACING LEAD| 5034 IMPLANTABLE PACING LEAD |