FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2171568
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-09749
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- June 4, 2011
- Report Date
- June 7, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION PROVIDED NOTED THAT THIS LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD.
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER A DEVICE REPLACEMENT SHOCKING IMPEDANCES ON THE RIGHT VENTRICULAR LEAD WERE OUT OF RANGE. THE LEAD WAS DISCONNECTED FROM THE DEVICE AND MEASURED IN DIFFERENT CONFIGURATION WHICH STILL SHOWED OUT OF RANGE SHOCKING IMPEDANCES. A LEAD FRACTURED WAS SUSPECTED. A LEAD REPLACEMENT WILL BE SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE 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 |