FDA Adverse Event
Malfunction
Summary report: N
ADAPTA
MDR report key: 2965248
·
Received February 15, 2013
Report
- Report Number
- 3004209178-2013-02145
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Report Date
- December 13, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. (B)(4). CONCOMITANT PRODUCT: 5076-52 IMPLANTABLE PACING LEAD, (B)(6) 2012.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT WHILE USING A CHAINSAW IT "FELT LIKE A PIN STICKING THE [PATIENT] IN PACEMAKER AREA." THE PATIENT WAS REFERRED TO SEE THE CARDIOLOGIST IF THERE CONTINUES TO BE A CONCERN. 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 |
|---|---|---|---|---|---|---|---|
| 67369 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5076-45 IMPLANTABLE PACING LEAD |