VIRTUOSO DR
Report
- Report Number
- 3004209178-2013-02035
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- December 5, 2012
- 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
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 4068 IMPLANTABLE PACING LEAD: (B)(6) 1997. 5866-38 ADAPTOR: (B)(6) 2008. 6721M IMPLANTABLE TACHY LEAD: (B)(6) 2008. (B)(4).
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE DEVICE HAD EARLY BATTERY DEPLETION. THE RIGHT VENTRICULAR LEADS WERE ALSO CAPPED DUE TO HIGH PACING THRESHOLD. THE DEVICE AND LEADS WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE DEVICE HAD EARLY BATTERY DEPLETION. THE RIGHT VENTRICULAR LEADS WERE ALSO CAPPED DUE TO HIGH PACING THRESHOLD. THE DEVICE AND LEADS WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55604 | VIRTUOSO DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D154AWG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00032 YR | Hospitalization| R | 5071 X2 IMPLANTABLE PACING LEADS |