FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2780130
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-12720
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 7, 2012
- Report Date
- September 7, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 THAT AT A CHANGE OUT PROCEDURE THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED NORMAL SHOCKING IMPEDANCES ON THIS RIGHT VENTRICULAR (RV) LEAD. HOWEVER, DURING THE SHOCK LEAD INTEGRITY TESTING (SLIT) GREATER THAN 125 OHMS WAS DETECTED. A DEFIBRILLATION THRESHOLD TESTING AT 17 JOULES RESULTED IN 51 OHMS. A SLIT WAS DONE AGAIN WITH GREATER THAN 125 OHMS NOTED. THE ICD WAS RECONFIRGURED TO RV TO CAN WHICH RESULTED IN 76 OHMS AND THE ICD WAS LEFT IN THIS CONFIGURATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | 0158| H219| H135| N164| 4513 |