FDA Adverse Event
Injury
Summary report: N
VIRTUOSO DR
MDR report key: 1925079
·
Received December 14, 2010
Report
- Report Number
- 6000144-2010-06203
- Event Type
- Injury
- Date Received
- December 14, 2010
- 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
- WA, US
- Reporter Occupation
- PATIENT
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 EXPERIENCED AN INCREASED HEART RATE AND NEAR SYNCOPE, AND THE DEVICE DID NOT DELIVER A THERAPY SHOCK. THE PATIENT ALSO VOICED HIS FRUSTRATION WITH THE DEVICE SETTINGS. THE DEVICE WAS REPROGRAMMED AND 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 | 70 YR | Life Threatening| R | 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |