FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK ENDURANCE
MDR report key: 2051990
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-04262
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 21, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, INFORMATION SUGGESTS THAT BOTH OF THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WIL BE FURTHER EVALUATED AND UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID EXHIBIT GREATER THAN 125 OHMS SHOCK IMPEDANCE ON MULTIPLE OCCASIONS OVER THE PAST MONTH. THERE WAS NO REPORT OF ADVERSE PATIENT SYMPTOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK ENDURANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | 4543| 4471| 4053| 0145| E110| N119| A155| 1831| 4592 |