FDA Adverse Event
Injury
Summary report: N
LINOX S 65
MDR report key: 2090017
·
Received May 4, 2011
Report
- Report Number
- 1028232-2011-01014
- Event Type
- Injury
- Date Received
- May 4, 2011
- Date of Event
- March 14, 2011
- Report Date
- April 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 LEAD WAS NOTED TO HAVE MICRO-DISLODGED AT A DEVICE CHECK. THE LEAD WAS SUCCESSFULLY REPOSITIONED ON (B)(6) 2011. ALL RECORDS INDICATE THAT THIS LEAD REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION 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 | 76 YR | Hospitalization |