FDA Adverse Event
Injury
Summary report: N
VIRTUOSO DR
MDR report key: 2951735
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01611
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- December 4, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LWS
- PMA / PMN Number
- P980016/S062
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 SUMMARY: A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS FOUND THE CAUSE OF THE HIGH CURRENT DRAIN TO BE CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. CONCOMITANT MEDICAL PRODUCTS: 6947 IMPLANTABLE TACHY LEAD: (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
THE DEVICE WAS REPLACED DUE TO EARLY BATTERY DEPLETION PRIOR TO REACHING 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 |
|---|---|---|---|---|---|---|---|
| 56834 | VIRTUOSO DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | D154AWG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Hospitalization| R | 1388T COMPETITOR IMPLANTABLE PACING LEAD |