FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3053623
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05029
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- June 6, 2012
- Report Date
- March 25, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P960040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT WILL BE BROUGHT INTO CLINIC AT A LATER DATE FOR FURTHER EVALUATION. RECORDS INDICATE THIS LEAD 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 DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. REVIEW OF DAILY MEASUREMENTS REVEALED THE PACING IMPEDANCE MEASUREMENTS HAD ALSO DECREASED ON THE SAME DATE. SUBSEQUENT MEASUREMENTS WERE WITHIN AN ACCEPTABLE RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154394 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | 1853| E110| 0155| T127| 4039 |