FDA Adverse Event
Injury
Summary report: N
LINOX S 65
MDR report key: 2212975
·
Received August 5, 2011
Report
- Report Number
- 1028232-2011-01759
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- February 24, 2010
- Report Date
- July 26, 2011
- 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
- NURSE
Narratives
Description of Event or Problem · 1
THIS PT EXPERIENCED SWELLING OF THE LEFT UPPER ARM WHICH MAY HAVE RESULTED FROM SUBCLAVIAN VEIN THROMBOSIS OF THE PACEMAKER WIRE. COUMADIN WAS ADMINISTERED AND NO FURTHER INTERVENTION IS ANTICIPATED. ALL RECORDS INDICATE THAT THIS LEAD REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX S 65 | ICD LEAD | LWS | BIOTRONIK SE & CO. KG | 351333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |