FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 2203536
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-04424
- 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
- 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 BY THE PATIENT FEELING ON TWO OCCASIONS "LIKE ELECTRICITY GOING THROUGH MY BODY" AND WONDERED IF IT COULD BE CAUSED BY THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT HAS NOT BEEN SEEN OR CONTACTED THE CLINIC. THE IPG 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 DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other | 5076 IMPLANTABLE PACING LEAD| 5054 IMPLANTABLE PACING LEAD |