FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2911192
·
Received January 11, 2013
Report
- Report Number
- 2124215-2012-16046
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Date of Event
- November 29, 2012
- Report Date
- November 29, 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 THROUGH A REMOTE MONITORING SYSTEM THAT THIS DEVICE DETECTED AN OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. TESTING WAS PERFORMED AND ALL OTHER MEASUREMENTS WERE CONFIRMED TO BE APPROPRIATE. A CONTINUOUS MEASUREMENT OF THE SHOCK IMPEDANCE MEASUREMENTS WERE CARRIED OUT AND MEASUREMENTS WERE NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18693 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | 4543| 4538| 4512| 0185| 4474| 4517| H175| H170| 0184 |