FDA Adverse Event
Injury
Summary report: N
XELOS DR-T
MDR report key: 1012591
·
Received March 12, 2008
Report
- Report Number
- 1028232-2008-00217
- Event Type
- Injury
- Date Received
- March 12, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 12, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER REP., THE PT EXPERIENCED VT/VF STORMS. THE DOCTOR CHOSE TO REMOVE THE DEVICE AND REPLACE IT WITH A *LUMAX 640 DR-T. THE VT/VF STORMS CONTINUED. THE DOCTOR ORDERED ICD THERAPY OFF TO ATTEMPT EXTERNAL DEFIBRILLATION, WHICH WAS UNSUCCESSFUL. THE DATE OF EXPLANT IS APPROXIMATE. THE PT EXPERIENCED IN LATE 2007. OTHER DEVICE TRIED: LUMAX 340 DR-T, 1028232-2008-00218.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XELOS DR-T | ICD | LWS | BIOTRONIK GMBH AND CO. | 350822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization |