FDA Adverse Event
Malfunction
Summary report: N
LINOX SD 65/16
MDR report key: 2132305
·
Received June 13, 2011
Report
- Report Number
- 1028232-2011-01286
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- June 2, 2011
- Report Date
- June 2, 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
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE PATIENT WAS SHOCKED INAPPROPRIATELY 7 TIMES FOR NOISE. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT NOISE WAS PRESENT ON BOTH LEADS AND THE FAR FIELD FOLLOWING A SHOCK. THE DOCTOR PERFORMED A SHOCK ON T INDUCTION AND NOISE WAS PRESENT FOLLOWING THE 1J SHOCK. THIS LED TO INAPPROPRIATE DETECTION AND THERAPY. THE SYSTEM IS SCHEDULED FOR EXPLANT. THE PATIENT MENTIONED THAT SHE FELL ABOUT A YEAR AGO AND HIT THE DEVICE POCKET AREA. AS OF TODAY, THIS SYSTEM REMAIN IMPLANTED.
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 | 67 YR | Hospitalization |