FDA Adverse Event
Injury
Summary report: N
LINOX SD 65/16
MDR report key: 1012592
·
Received March 12, 2008
Report
- Report Number
- 1028232-2008-00214
- Event Type
- Injury
- Date Received
- March 12, 2008
- Date of Event
- January 15, 2008
- Report Date
- February 11, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THIS LEAD WAS RETURNED WITH OOS DOCUMENTATION FROM A BIOTRONIK REP. THIS LEAD WAS SENSING INAPPROPRIATELY AND THE SYSTEM WAS GIVING INAPPROPRIATE SHOCKS. THE VENTRICLE LEAD WAS REPOSITIONED ONCE, AND WHEN THE INAPPROPRIATE SENSING AND SHOCKS CONTINUED, THE WHOLE SYSTEM WAS REMOVED. IT WAS REPLACED WITH LINOX SD 65/16. AFTER THE SYSTEM WAS EXCHANGED, THE DOCTOR AND REP WERE TOLD THAT THE PATIENT HAD BEEN SLEEPING ON AN ELECTRIC BED. ALSO REMOVED: LUMAX 340 DR-T, 1028232-2008-00215. SETROX S 45,1028232-2008-00213.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 65/16 | ICD LEAD | LWS | BIOTRONIK GMBH AND CO. | 350053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization |