FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3223565
·
Received July 12, 2013
Report
- Report Number
- 2124215-2013-10331
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 7, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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Additional Manufacturer Narrative · 1
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 RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED THAT LED TO LOSS OF MYOCARDIAL CAPTURE. THE PATIENT WAS REPORTED TO BE DEPENDENT AND RESPONDED TO BIVENTRICULAR CONFIGURATION AND ONLY THE LEFT VENTRICULAR (LV) LEAD WAS PACING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED OPTIONS FOR REVISION. ADDITIONAL INFORMATION INDICATED THAT THE HIGH VOLTAGE PORTION REMAINS ACTIVE AND THE P/S PORTION OF THE LEAD WAS SURGICALLY WAS CAPPED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322011 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| L| R | 6987| N119| H177| 6947| 0181| 0187| 5071| 7076| 5076| H217| 1882TC| 0184 |