FDA Adverse Event
Death
Summary report: N
VIRTUOSO VR
MDR report key: 1923510
·
Received December 14, 2010
Report
- Report Number
- 2647346-2010-00919
- Event Type
- Death
- Date Received
- December 14, 2010
- Date of Event
- December 3, 2009
- 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
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ASKU
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA KNOWN AT THE TIME OF THIS REPORT. HOWEVER, THE CAUSE OF DEATH HAS BEEN REQUESTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2009 APPROXIMATELY EIGHT MONTHS AFTER DEVICE AND LEAD REPLACEMENT. FOLLOW UP WITH THE CLINIC REPORTED THE DEVICE THERAPIES WERE TURNED OFF "AS PATIENT WAS IN HOSPICE" AND THE PATIENT DIED THE FOLLOWING DAY. THE CAUSE OF DEATH IS UNKNOWN TO THE CLINIC.
Description of Event or Problem · 1
INFORMATION NOTED THE PATIENT DIED APPROXIMATELY EIGHT MONTHS POST IMPLANT OF THE TACHY DEVICE SYSTEM. NO FURTHER INFORMATION IS CURRENTLY KNOWN. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.
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 | 82 YR | Death |