FDA Adverse Event
Malfunction
Summary report: N
ADAPTA
MDR report key: 3051498
·
Received April 10, 2013
Report
- Report Number
- 3004209178-2013-05963
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- February 27, 2013
- Report Date
- February 27, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WORE THEIR SPOUSE'S "LOOP" AND EXPERIENCED SYMPTOMS SIMILAR TO ATRIAL FIBRILLATION (AF), HEART REALLY POUNDING AND ALSO FELT NAUSEOUS. THE PATIENT REMOVED THE LOOP AND FELT BETTER IMMEDIATELY. 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 |
|---|---|---|---|---|---|---|---|
| 150013 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADSR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | 5024 IMPLANTABLE PACING LEAD |