FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 3760941
·
Received April 21, 2014
Report
- Report Number
- 2124215-2014-08831
- Event Type
- Injury
- Date Received
- April 21, 2014
- Date of Event
- February 10, 2012
- Report Date
- February 20, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- PMA / PMN Number
- P010012
- Adverse Event
- Yes
- 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 THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. ADDITIONALLY THE LEAD WAS EXHIBITING NOISE AND INCREASING THRESHOLD MEASUREMENTS. THE LOCAL AREA FIELD REPRESENTATIVE REPORTED THERE WAS NO PACING INHIBITION OR ASYSTOLE. A REVISION PROCEDURE WAS PERFORMED AND THE RATE SENSE PORTION OF THE RV LEAD WAS CAPPED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240251 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | E102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| L| R | E102| 1763| 1860| 0125 |