FDA Adverse Event
Injury
Summary report: N
VIRTUOSO DR
MDR report key: 3152973
·
Received June 8, 2013
Report
- Report Number
- 3004209178-2013-08867
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 29, 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
- MN, 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. PRODUCT: 5076-52 IMPLANTABLE PACING LEAD, (B)(6) 2007; 5092-58 IMPLANTABLE PACING LEAD, (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
THE DEVICE WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254711 | VIRTUOSO DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D154AWG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Hospitalization| R | 6944-65 IMPLANTABLE TACHY LEAD |