FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 1952025
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23253
- Event Type
- Malfunction
- Date Received
- January 7, 2011
- Date of Event
- October 27, 2010
- Report Date
- December 2, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE ON THE RIGHT ATRIAL (RA) LEAD AFTER POCKET CLOSURE. INTERVENTION WAS PERFORMED, HOWEVER IT WAS DETERMINED TO MOST LIKELY BE AIR BUBBLES IN THE DEVICE HEADER. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4) |