FDA Adverse Event
Injury
Summary report: N
LINOX SD 60/16
MDR report key: 1770163
·
Received July 19, 2010
Report
- Report Number
- 1028232-2010-01528
- Event Type
- Injury
- Date Received
- July 19, 2010
- Date of Event
- March 31, 2010
- Report Date
- June 29, 2010
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER (B) (4) ADVERSE EVENT REPORT, ALL THREE OF THIS PT'S LEADS WERE DETERMINED TO BE DISLODGED BY CHEST X-RAY ON (B) (6)2010. ALL LEADS WERE SUCCESSFULLY REPOSITIONED ON (B) (6)2010, AND REMAIN IMPLANTED. SHOULD ADD'L INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED. SETROX S 45, (B) (4), MDR 1028232-2010-01526; COROX OTW-S 75-BP, (B) (4), MDR 1028232-2010-01527.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 60/16 | ICD LEAD | LWS | BIOTRONIK SE & CO. KG | 363303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization |