FDA Adverse Event
Injury
Summary report: N
VIRTUOSO DR
MDR report key: 2130080
·
Received June 16, 2011
Report
- Report Number
- 6000144-2011-03299
- Event Type
- Injury
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S062
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYSIS REVEALED THAT THE BATTERY DEPLETION WAS NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD HAD A HIGH THRESHOLD AND THE DEVICE HAD AN EARLY ELECTIVE REPLACEMENT INDICATOR (ERI) AND HIGH ATRIAL OUTPUT. THE LEAD WAS CAPPED AND THE DEVICE WAS REMOVED; ANOTHER LEAD WAS IMPLANTED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIRTUOSO DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154AWG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD |