FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3053164
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-04775
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 15, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEFIBRILLATION LEAD PRESENTED WITH CHEST PAIN. A CHEST X-RAY WAS PERFORMED AND NO ANOMALIES WERE NOTED. DEVICE INTERROGATION REVEALED LOSS OF CAPTURE. A COMPUTED TOMOGRAPHY SCAN WAS THEN PERFORMED WHICH SHOWED THIS LEAD HAD PERFORATED THE RIGHT VENTRICLE APEX. AN INVASIVE PROCEDURE WAS PERFORMED AND THIS LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155250 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization| L| R | E160| 0296 |