FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2153590
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-06464
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- April 10, 2011
- Report Date
- May 6, 2011
- 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
OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION VIA LATITUDE RED ALERT, THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED LOW SHOCK IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS BROUGHT IN FOR EVALUATION AND THE EVERYTHING TESTED NORMAL; HOWEVER, A FULL ENERGY SHOCK WAS NOT PERFORMED. AT THIS TIME, THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT.
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 | 72 YR | 4087| 0180| 4469| E110| 0185| T165 |