FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 1991214
·
Received February 15, 2011
Report
- Report Number
- 6000144-2011-00847
- Event Type
- Malfunction
- Date Received
- February 15, 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
- NV, 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 HEART RATE DROPPED TO A LOW RATE, AND THE PATIENT IS CONCERNED THAT THE DEVICE MAY NOT BE PROGRAMMED CORRECTLY, OR SOMETHING MIGHT BE WRONG WITH THE DEVICE. THE PATIENT ALSO REPORTED FEELING "WEIRD", WEAK, AND SHAKY. 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 | 85 YR | Other | (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD |