FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 2130777
·
Received June 16, 2011
Report
- Report Number
- 6000144-2011-03401
- Event Type
- Malfunction
- Date Received
- June 16, 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
- MN, 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. EVALUATION SUMMARY FOR (B)(4).: THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE FAILED FOR NO TELEMETRY WHILE STILL IN THE BOX. THERE WAS NO PATIENT INVOLVEMENT AND 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 | Other |