FDA Adverse Event
Malfunction
Summary report: N
LINOX SD 65/18
MDR report key: 2151391
·
Received June 8, 2011
Report
- Report Number
- 1028232-2011-01258
- Event Type
- Malfunction
- Date Received
- June 8, 2011
- Date of Event
- April 29, 2011
- Report Date
- June 2, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THIS PT WAS LOST-TO-SYSTEM AND ARRIVED AT THE HOSPITAL DUE TO MULTIPLE INAPPROPRIATE SHOCKS BEING DELIVERED. AFTER AN X-RAY WAS TAKEN, IT WAS CLEAR THE LEAD HAD BEEN FRACTURED DUE TO 1ST- RIB ENTRAPMENT. THEREFORE, IT WAS CAPPED. THE DEVICE WAS FINE AND IS STILL ACTIVELY IMPLANTED. PT WAS SEEN JUST A FEW DAYS AGO AND IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 65/18 | ICD LEAD | LWS | BIOTRONIK SE & CO. KG | 350054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization |