FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 1951051
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-23812
- Event Type
- Malfunction
- Date Received
- January 6, 2011
- Date of Event
- November 18, 2010
- Report Date
- November 18, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A CONSULTATION WITH THE PHYSICIAN HAS BEEN SCHEDULED. AT THIS TIME, THE CRT-D REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED WITH ABNORMAL INCREASE IN PACING IMPEDANCE MEASUREMENTS. THE LEAD ASSOCIATED WITH THIS DEVICE IS A COMPETITOR'S PRODUCT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SERIAL NUMBER FOR THIS DEVICE IS CURRENTLY UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |