FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1944467
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-19630
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 6, 2010
- Report Date
- October 6, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS IMPLANTED AND ONE DAY POST OPERATION, HIGH SHOCKING IMPEDANCE MEASUREMENTS WERE NOTED TO BE GREATER THAN 125 OHMS. IT WAS DETERMINED THAT THE SETSCREW WAS NOT FULLY ENGAGED UPON POCKET REVISION. THE LEAD WAS REINSERTED INTO THE HEADER AND PROPERLY TIGHTENED DOWN. IMPEDANCE MEASUREMENTS WERE THEN NOTED TO BE WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | T125| 4470| 0185 |