FDA Adverse Event
Malfunction
Summary report: N
ADAPTA
MDR report key: 2955609
·
Received February 11, 2013
Report
- Report Number
- 3004209178-2013-02108
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Report Date
- December 17, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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. CONCOMITANT PRODUCTS: 1388T COMPETITOR IMPLANTABLE PACING LEAD 1999 (B)(6). (B)(4).
Description of Event or Problem · 1
THE PATIENT CALLED TO REPORT THAT THEIR DEVICE'S BATTERY LIFE IS DEPLETING SOONER THAN EXPECTED. 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 |
|---|---|---|---|---|---|---|---|
| 59882 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDRL1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) IMPLANTABLE PACING LEAD |