FDA Adverse Event
Malfunction
Summary report: N
VIRTUOSO VR
MDR report key: 2053528
·
Received April 13, 2011
Report
- Report Number
- 6000144-2011-01633
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S062
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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'S WIFE CALLED TO REPORT THAT THE PATIENT FELL. SHE REPORTED THAT THE AREA AROUND THE DEVICE WAS SWOLLEN, BUT NOW IT FEELS "SUNKEN." SHE ALSO STATED THAT THE PATIENT HAS NOT BEEN FEELING WELL. FURTHER FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIRTUOSO VR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154VWC | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other | (B)(4) IMPLANTABLE TACHY LEAD |