FDA Adverse Event
Injury
Summary report: N
ADAPTA
MDR report key: 2955603
·
Received February 11, 2013
Report
- Report Number
- 3004209178-2013-02106
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- November 30, 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
- NC, 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 PRODUCT: 5568 NON-DEFIB LEAD (B)(6) 2010. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT "THE BATTERY WAS BEING USED UP MORE THAN IT HAD TO BE" AND "THEY COULD FEEL THAT SENSATION". THE DEVICE WAS REPROGAMMED AND SINCE THEN, THE PATIENT HAS HAD 3 INCIDENCES WHERE THEIR LEFT ARM IS NUMB FROM THE ELBOW TO THE FINGERTIPS. 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 |
|---|---|---|---|---|---|---|---|
| 59058 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 5076 NON-DEFIB LEAD |