FDA Adverse Event
Malfunction
Summary report: N
LINOX SD 65/16
MDR report key: 2190071
·
Received June 29, 2011
Report
- Report Number
- 1028232-2011-01449
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Date of Event
- May 26, 2011
- Report Date
- June 24, 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 IMPLANT DURATION OF ABOUT 30 MONTHS, IT WAS REPORTED THAT THE ASSOCIATED ICD COULD NOT BE INTERROGATED. THIS LEAD AND THE ASSOCIATED DEVICE WERE EXPLANTED. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED.
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 |