TELIGEN
Report
- Report Number
- 2124215-2012-16419
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- December 4, 2012
- Report Date
- January 27, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
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SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.
ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THAT A REVISION TOOK PLACE TO UPGRADE TO A NEW DEVICE.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A REPLACEMENT PROCEDURE IN (B)(6) 2012, POST OPERATIVE TESTING SHOWED VARYING PACING IMPEDANCES AND SLIGHTLY HIGHER COMPARED TO IMPEDANCES WITH THE PREVIOUSLY IMPLANTED DEVICE. THE CONNECTION WAS CONFIRMED. POCKET MANEUVERS WERE PERFORMED WHICH SHOWED NO INTERFERENCE AND THE PACE/SENSE AMPLITUDES REMAINED SIMILAR TO THE PREVIOUSLY IMPLANTED DEVICE. TECHNICAL SERVICES ADVICE WAS REQUESTED. TECHNICAL SERVICES DISCUSSED THE VARYING IMPEDANCES OVER THE LIFE TIME OF THIS RIGHT VENTRICULAR LEAD. THE NEWLY IMPLANTED DEVICE AND LEAD REMAINED IMPLANTED. SUBSEQUENTLY, A FOLLOW UP TOOK PLACE 9 MONTHS LATER AND OUT OF RANGE PACING IMPEDANCES WERE NOTED ON THIS RIGHT VENTRICULAR LEAD. IT WAS NOTED THAT THE PACING IMPEDANCES WERE OUT OF RANGE FOR AT LEAST THREE MONTHS. NORMAL FOLLOW UPS WERE SCHEDULED. ALL OTHER VALUES APPEARED TO BE NORMAL SINCE THE IMPLANT PROCEDURE.
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17798 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | 0175| 1870| F102 |