FDA Adverse Event
Malfunction
Summary report: N
ADAPTA
MDR report key: 2954559
·
Received February 11, 2013
Report
- Report Number
- 3004209178-2013-02461
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Report Date
- December 20, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT CANNOT SUSTAIN INCREASED ACTIVITY LEVELS DUE TO THEIR "HEART RATE IS NOT KEEPING UP". FURTHER INFORMATION RELATED TO THIS EVENT WAS UNABLE TO BE OBTAINED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59634 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5076 X 2 IMPLANTABLE PACING LEADS |