FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3212461
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09340
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 29, 2013
- Report Date
- October 2, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON ADDITIONAL INFORMATION, THIS INVESTIGATION WILL BE UPDATED.
Additional Manufacturer Narrative · 1
IT WAS NOTED THAT THE LEAD WAS EXPLANTED. IT IS NOT KNOW IF THE LEAD WILL BE RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE, OVERSENSING RESULTING IN ANTI TACHYCARDIA THERAPY WAS DELIVERED TO THE PATIENT. FURTHER REVIEW OF DAILY MEASUREMENTS NOTED THAT SOME VALUES WERE LOW OUT OF RANGE, AND A RIGHT VENTRICULAR LEAD INSULATION ISSUE WAS SUSPECTED. THE PATIENT WAS HOSPITALIZED AND ANOTHER PROCEDURE TO IMPLANT A NEW LEAD WILL BE SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311902 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |