FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 1873873
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-17947
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Date of Event
- August 4, 2010
- Report Date
- September 3, 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
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THERE WERE HIGH OUT OF RANGE SHOCKING IMPEDANCE GREATER THAN 125 OHMS WITH THE CHRONIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. THE DEVICE WAS IN THE POCKET AND THE SHOCK CONFIGURATION WAS PROGRAMMED RV TO CAN. THE LEAD WAS DISCONNECTED AND RECONNECTED AND THE SHOCK IMPEDANCES RETURNED TO NORMAL RANGE. THE DEVICE REMAINS IN SERVICE WITH THE CHRONIC RV LEAD. 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 | 59 YR | (B)(4)| (B)(4)| (B)(4)| (B)(4) |