FDA Adverse Event
Injury
Summary report: N
PROTECTA XT DR
MDR report key: 3160442
·
Received June 10, 2013
Report
- Report Number
- 3004209178-2013-10076
- Event Type
- Injury
- Date Received
- June 10, 2013
- Report Date
- April 30, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
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 THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING AN INAPPROPRIATE THERAPY FROM THE DEFIBRILLATOR. IT WAS DETERMINED BY REMOTE TRANSMISSION THE PATIENT HAD EPISODES OF ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE RESULTING IN INAPPROPRIATE THERAPY. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259420 | PROTECTA XT DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D314DRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Hospitalization| L | 6947 IMPLANTABLE TACHY LEAD |