FDA Adverse Event
Injury
Summary report: N
ADAPTA
MDR report key: 2965103
·
Received February 15, 2013
Report
- Report Number
- 3004209178-2013-02130
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- December 17, 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
- TN, US
- Reporter Occupation
- PHYSICIAN
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 PRODUCTS CONTINUED: 4260 IMPLANTABLE PACING LEAD (B)(6) 1989. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS IN ER (EMERGENCY ROOM) AND THE DEVICE WAS JUST STARTED TO BE INTERROGATED AND THERE WAS A RESET MESSAGE AND AFTER THAT THEY COULD NOT GET TELEMETRY BACK. THE PATIENT WENT IN VFIB (VENTRICULAR FIBRILLATION) WHILE ATTEMPTING TO ESTABLISH TELEMETRY AND WAS SUCCESSFULLY SHOCKED OUT OF IT. IT WAS ALSO NOTED THAT THERE WAS NO PACING FROM THE DEVICE AND THE DEVICE WAS DEAD. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67427 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDR03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR | Hospitalization| L| R | 407645 IMPLANTABLE PACING LEAD |