FDA Adverse Event
Malfunction
Summary report: N
LINOX SD 75/18
MDR report key: 2082012
·
Received April 25, 2011
Report
- Report Number
- 1028232-2011-00907
- Event Type
- Malfunction
- Date Received
- April 25, 2011
- Date of Event
- April 13, 2011
- Report Date
- April 14, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
UPON REVIEW OF CINE FILM TAKEN DURING A LEFT HEART CATHETERIZATION FOR THIS PT, AN ANOMALY IN THE PHYSICAL APPEARANCE OF THE LEAD WAS NOTED PROXIMAL TO THE SVC SHOCKING COIL. HOME MONITORING RECORDINGS INDICATE CONSISTENT IN RANGE MEASUREMENTS. NO ADDITIONAL COMPLAINTS CONCERNING THE FUNCTIONALITY OF THE LEAD ARE NOTED. NO ADVERSE EVENTS ARE REPORTED FOR THIS PT. THE LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 75/18 | ICD LEAD | LWS | BIOTRONIK SE & CO. KG | 350056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |