FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3210265
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-09177
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 22, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS, INAPPROPRIATE SENSING OF SUPRAVENTRICULAR TACHYCARDIA (SVT) AND WAS OBSERVED TO HAVE FRACTURED. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310105 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| L| R | 4086| 0180| 0174| 4135| E110 |