FDA Adverse Event
Injury
Summary report: N
VIRTUOSO DR
MDR report key: 1992623
·
Received February 15, 2011
Report
- Report Number
- 6000144-2011-01016
- Event Type
- Injury
- Date Received
- February 15, 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
- OH, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED SHOCKS DUE TO NOISE WHEN SHE ENTERED HER POOL. THE POOL WAS PROFESSIONALLY CHECKED OUT AND WAS "CLEARED." AFTER SOME TIME, THE PATIENT "BUILT UP ENOUGH COURAGE TO TAKE ANOTHER ATTEMPT AT THE POOL ONLY TO GET SHOCKED AGAIN." THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE 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 | 73 YR | Life Threatening | 4269 COMPETITOR IMPLANTABLE PACING LEAD| 0125 COMPETITOR IMPLANTABLE TACHY LEAD |