FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3041124
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-01332
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- January 12, 2013
- Report Date
- January 16, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 FROM A PRODUCT EXPERIENCE REPORT (PER) FORM THAT WHEN THE REPLACEMENT DEVICE WAS CONNECTED TO THE CHRONIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, A GREATER THAN 200 OHMS SHOCK IMPEDANCE WAS RECORDED IN ALL SHOCK CONFIGURATIONS EXCEPT RV (COIL) TO CAN. THE LOCAL REPRESENTATIVE SUSPECTS THAT THE RV DEFIBRILLATION LEAD MAY HAVE BEEN DAMAGED DURING THE REPLACEMENT PROCEDURE. THE CHRONIC RV DEFIBRILLATION LEAD WAS SURGICALLY CAPPED AND REPLACED. THE REPLACEMENT DEVICE REMAINS IN-SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143006 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | 4525| 4470| 0186| H179| 4518| N118 |