FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 1980980
·
Received February 8, 2011
Report
- Report Number
- 2124215-2011-02190
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- September 17, 2009
- Report Date
- December 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
THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED OUT OF RANGE DAILY SHOCK IMPEDANCE MEASUREMENTS. SHOCK IMPEDANCE MEASUREMENTS WITH SHOCK DELIVERY WERE WITHIN RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | MISMATCH| 1789| 1857| (B)(4)| 0041| 1600| 1550| E102| 6931| 6024| 1746| 4312 |