FDA Adverse Event
Injury
Summary report: N
PROTECTA VR
MDR report key: 3051815
·
Received April 10, 2013
Report
- Report Number
- 3004209178-2013-05974
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- February 20, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED ENDOCARDITIS AND THAT THE RIGHT VENTRICULAR LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WERE EXPLANTED AND A FUTURE REPLACEMENT WAS PLANNED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149349 | PROTECTA VR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D334VRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00048 YR | Hospitalization| R | 694765 IMPLANTABLE TACHY LEAD |