FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3041263
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-03271
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- January 14, 2013
- Report Date
- June 26, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
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Additional Manufacturer Narrative · 1
ACCORDING TO OUR RECORDS THIS LEAD REMAINS IMPLANTED AT THIS TIME. THIS REPORT BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
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Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED OUT OF RANGE IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS AND NOISE. TWO INAPPROPRIATE SHOCKS DELIVERED RESULTING FROM THE NOISE. THE PATIENT HAS A NON BOSTON SCIENTIFIC DEVICE. A LEAD REVISION WAS TO OCCUR BECAUSE OF EVIDENCE OF A FRACTURE FOUND. A REQUEST FOR LEAD STATUS WAS SENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143876 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Life Threatening| R | 0184| MISMATCH |