FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3041184
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-01278
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- January 10, 2013
- Report Date
- January 25, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED TISSUE ENTWINED IN THE HELIX. NO IRREGULARITIES NOTED AT THE TIP REGION OF LEAD THAT COULD CONTRIBUTE TO DISLODGMENT. THE LABORATORY WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS.
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.
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 HAD DISLODGED APPROXIMATELY SIX MONTHS POST IMPLANT. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142531 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| L| R | 0295| E140| 0292 |