FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2905486
·
Received January 9, 2013
Report
- Report Number
- 2124215-2012-16149
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- August 9, 2012
- Report Date
- October 1, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS PART OF AN IMPLANTED SYSTEM THAT EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE PHYSICIAN WAS GOING TO CONTACT THE PATIENT SOON FOR A CLINICAL FOLLOW UP. THE PHYSICIAN ALSO STATED THE HIGH SHOCK IMPEDANCE VALUES WERE A KNOWN ISSUE SINCE IMPLANT AND NO REVISION WOULD BE PLANNED AT THIS TIME. PATIENT HAS NOT RECEIVED SHOCKS. NO ADVERSE EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12133 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |