FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3212938
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09129
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- May 24, 2013
- Report Date
- June 7, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
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 AN ALERT WAS TRIGGERED DUE TO HIGH OUT OF RANGE SHOCK IMPEDANCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THAT THE PATIENT HAD A SHOCK TEST IN 2012 TO MAKE SURE THE SYSTEM WAS WORKING APPROPRIATELY DESPITE OUT OF RANGE VALUES. AT THIS TIME THE SYSTEM REMAINS IMPLANTED AND THE PHYSICIAN ELECTED NOT TO FOLLOW THE PATIENT VIA LATITUDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312195 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |