FDA Adverse Event
Injury
Summary report: N
CAPSUREEPI
MDR report key: 3953709
·
Received July 23, 2014
Report
- Report Number
- 2182208-2014-01866
- Event Type
- Injury
- Date Received
- July 23, 2014
- Date of Event
- July 1, 2014
- Report Date
- July 24, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NVN
- PMA / PMN Number
- P950024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 PRODUCT: 4965 LEAD IMPLANTED: (B)(6) 2003.
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS HIGH IMPEDANCE AND CONFIRMED FRACTURES OF THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS. THE LEADS WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 432407 | CAPSUREEPI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MEDTRONIC, INC. | 4965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00014 YR | Hospitalization| R | SEDR01 IPG |