FDA Adverse Event
Malfunction
Summary report: N
ADAPTA
MDR report key: 2952891
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01832
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- September 28, 2012
- Report Date
- November 26, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 BY THE PATIENT THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS GOING TOO FAST AND THE PATIENT COULD NOT SLEEP. THE PATIENT WANTED REPROGRAMMING DONE AND WAS RECOMMENDED TO CONTACT THE CLINIC. 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 |
|---|---|---|---|---|---|---|---|
| 56347 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADSR06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00084 YR | 322-165 COMPETITOR IMPLANTABLE PACING LEAD |