FDA Adverse Event
Malfunction
Summary report: N
LINOX SD 65/16
MDR report key: 2140267
·
Received June 13, 2011
Report
- Report Number
- 1028232-2011-01272
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 18, 2011
- Report Date
- June 1, 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
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OUS MDR.
Description of Event or Problem · 1
OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 20 MONTHS, THIS DEVICE WAS EXPLANTED DUE TO OVERSENSING AND INAPPROPRIATE SHOCK. THE DATE OF IMPLANT WAS NOT PROVIDED OTHER THAN IT WAS IMPLANTED SOMETIME IN (B)(6) 2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 65/16 | ICD LEAD | LWS | BIOTRONIK SE & CO. KG | 350053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |