FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 1792336
·
Received August 11, 2010
Report
- Report Number
- 6000144-2010-03216
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- May 4, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD A POWER ON RESET WHILE IN THE BOX, AND THE LONGEVITY ESTIMATE WAS ONLY 11 MONTHS. THE DEVICE WAS NOT IMPLANTED. THE ISSUE WAS DETECTED PRIOR TO ANY PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDRS1 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |