VIRTUOSO DR
Report
- Report Number
- 3004209178-2013-01811
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 26, 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
- IA, 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 PRODUCT: 5076, IMPLANTABLE PACING LEAD, (B)(6) 2008. (B)(4).
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS REVEALED THE THERE WAS AN ALERT FOR A LOW BATTERY VOLTAGE AT RECOMMENDED REPLACEMENT TIME (RRT). TIME OF RRT IN SAVE TO DISK ON (B)(6) 2012 DEVICE RRT LESS THAN EQUAL TO 2.62 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT EQUAL TO 2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. ALSO, A LOW BATTERY VOLTAGE ALERT ON (B)(6) 2012.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) WITHIN FOUR AND A HALF YEARS AND THE LONGEVITY WAS UNEXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57570 | VIRTUOSO DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D154AWG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00047 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD |