FDA Adverse Event
Injury
Summary report: N
ENTRUST VR
MDR report key: 2964951
·
Received February 15, 2013
Report
- Report Number
- 3004209178-2013-02264
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- February 20, 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
- IN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. A POWER ON RESET (POR) OCCURRED ON (B)(6) 2012 AT ADDRESS 1D DF.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD A POWER-ON-RESET. IT WAS NOTED THAT THE PATIENT WAS RECEIVING RADIATION THERAPY. THE DEVICE WAS INTERROGATED AND 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 |
|---|---|---|---|---|---|---|---|
| 68710 | ENTRUST VR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D154VRC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Required Intervention | 6949 IMPLANTABLE DEFIBRILLATOR LEAD |