FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN
MDR report key: 2911745
·
Received January 11, 2013
Report
- Report Number
- 2124215-2012-16614
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Date of Event
- December 7, 2012
- Report Date
- December 7, 2012
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- Product Code
- NHW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 THIS CHRONIC LEAD HAS EXHIBITED AN INCREASED PACING IMPEDANCE AND IT IS NOW GREAT THAN 2100 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED THE LEAD MAY BE FAILING AS THERE ARE NUMEROUS REPORTS IN THE PAST SPEAKING TO INCREASED IMPEDANCES, HOWEVER, THE PATIENT REFUSES TO GET ANY FURTHER TREATMENT. THE LEAD REMAINS IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18664 | UNKNOWN | IMPLANTABLE LEAD | NHW | GUIDANT ANGLETON/ST. PAUL | 439-07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | 439-07| 439-04| MISMATCH |