FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2780190
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-12349
- Event Type
- Injury
- Date Received
- October 10, 2012
- Date of Event
- August 31, 2012
- Report Date
- September 1, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RECORDS INDICATE THIS PRODUCT REMAINS IN SERVICE. 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 THIS IMPLANTABLE DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. AN X-RAY WAS PERFORMED AND NO LEAD ANOMALIES WERE NOTED. A MINIMUM AND MAXIMUM ENERGY SHOCK WERE DELIVERED WHICH YIELDED SHOCK IMPEDANCE MEASUREMENTS OF 79 AND 80 OHMS. NO FURTHER EVALUATION WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Life Threatening| R | 0184| E110| 4469| A155 |