FDA Adverse Event
Malfunction
Summary report: N
CARDIFIX
MDR report key: 3213557
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-08630
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- January 21, 2013
- Report Date
- May 21, 2013
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WHEN REMOVING THE RIGHT VENTRICULAR (RV) LEAD, THE DISTAL PIN SEPARATED FROM THE RING. THE COIL LOOKED FINE AND WAS PUT THINGS BACK TOGETHER. THE RV LEAD FUNCTION WAS GOOD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313711 | CARDIFIX | IMPLANTABLE LEAD | NVN | GUIDANT ANGLETON/ST. PAUL | 438-07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | (B)(4)| (B)(4)| K173| 1298 |