FDA Adverse Event
Malfunction
Summary report: N
ADAPTA
MDR report key: 2952856
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01815
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- August 30, 2012
- Report Date
- November 30, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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: 5076 NON-DEFIB LEAD (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT EVERY TIME THEY RIDE OR DRIVE A VEHICLE, THEIR "HEART STARTS DEFIBRILLATING FASTER". THE PATIENT WAS ADVISED TO FOLLOW UP WITH THEIR PHYSICIAN. 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 |
|---|---|---|---|---|---|---|---|
| 56034 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | 5076 NON-DEFIB LEAD |