FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3210133
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-07205
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 15, 2013
- Report Date
- March 24, 2016
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- PMA / PMN Number
- P910073/S041
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
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. THE CURRENT VALUES REMAINS STABLE BUT OUT OF RANGE. THE PHYSICIAN ELECTED TO MONITOR THIS PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310492 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | BOSTON SCIENTIFIC CORPORATION | 0161 | ||
| 310493 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | BOSTON SCIENTIFIC CORPORATION | 0161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |