FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3905409
·
Received July 1, 2014
Report
- Report Number
- 2124215-2014-10899
- Event Type
- Injury
- Date Received
- July 1, 2014
- Date of Event
- May 8, 2014
- Report Date
- May 8, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INV...
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD AND DEVICE RECEIVED TWELVE INAPPROPRIATE SHOCKS DUE TO OVERSENSING ATRIAL FLUTTER. THIS LEAD HAD DISLODGED INTO THE RIGHT ATRIUM. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. POST REPOSITION, THE LEAD APPEARED TO BE FUNCTIONING APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 383457 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R | 0295| E142| 4136 |