FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 2203406
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-04092
- 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
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO BE INTERROGATED. IT WAS SUGGESTED TO TRY AGAIN AND TURN THE PROGRAMMER HEAD OVER. THE DEVICE 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. | ADDRL1 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other | 5071 (X2) IMPLANTABLE PACING LEAD| E2DR01 IMPLANTABLE PULSE GENERATOR| 4965 IMPLANTABLE PACING LEAD| 4068 (X2) IMPLANTABLE PACING LEAD| 586638M IMPLANTABLE LEAD ADAPTOR |