FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2053257
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04576
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- February 24, 2010
- Report Date
- March 4, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO INTERVENTION WAS REQUIRED. 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, DURING DEFIBRILLATION THRESHOLD TESTING AT AN IMPLANT, THIS DEVICE LOST TELEMETRY CONNECTION WITH A PROGRAMMER. DUE TO THE LOSS OF TELEMETRY, THE DEVICE ELECTROGRAMS COULD NOT BE SEEN DURING SENSING. 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 | F103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |