FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 2203491
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-04189
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- 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
- US
- Reporter Occupation
- PATIENT
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 STATED THAT HAVING EXTREME FATIGUE AND COULD SLEEP ALL DAY. OTHER THAN THAT, THE PATIENT FEELING OK, AND ENCOURAGED PATIENT TO CONTACT MEDICAL DOCTOR. THE DEVICE IS STILL 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 DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other | 5076 (X2) IMPLANTABLE PACING LEAD |