FDA Adverse Event
Injury
Summary report: N
CAPSURE EPI
MDR report key: 2954534
·
Received February 11, 2013
Report
- Report Number
- 2182208-2013-00448
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- December 20, 2012
- Report Date
- December 20, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- NVN
- PMA / PMN Number
- P950024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4968 EPICARDIAL PACING LEAD, (B)(6) 2011; 4965 EPICARDIAL PACING LEAD, (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS AN ATTEMPT TO REPLACE AN EPICARDIAL SYSTEM TO ENDOCARDIAL SYSTEM DUE TO POCKET NOISE CAUSED BY THE RIGHT ATRIAL (RA) EPICARDIAL LEAD. AN ENDOCARDIAL RA LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59405 | CAPSURE EPI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | RICE CREEK MFG | 4965-35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00027 YR | Hospitalization| R | C4TR01 IMPLANTABLE BI-VENTRICULAR PACEMAKER |