FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2053316
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-05061
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 3, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 DEVICE WAS PROGRAMMED TO "TACHY MODE OTHER THAN MONITOR PLUS (+) THERAPY". DEVICE REPROGRAMMING REASON WAS UNKNOWN. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, ADDITIONAL INFORMATION WAS UNAVAILABLE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.
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 | 84 YR | E110| 0158| 5076 |