FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 1864043
·
Received October 11, 2010
Report
- Report Number
- 2124215-2010-15855
- Event Type
- Malfunction
- Date Received
- October 11, 2010
- Date of Event
- August 6, 2010
- Report Date
- August 6, 2010
- 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
ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE LATITUDE SYSTEM DETECTED A RED ALERT FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO LOW SHOCK IMPEDANCES. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS BROUGHT TO THEIR CLINIC FOR FOLLOW-UP, DURING WHICH ALL LEAD MEASUREMENTS WERE NOTED TO BE NORMAL; THUS THE PATIENT WILL CONTINUE TO BE MONITORED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO 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 | 87 YR | 0144| 4054| 1851| A155| E110 |