FDA Adverse Event
Injury
Summary report: N
CAPSUREEPI
MDR report key: 3855221
·
Received June 9, 2014
Report
- Report Number
- 2649622-2014-04879
- Event Type
- Injury
- Date Received
- June 9, 2014
- Date of Event
- May 12, 2014
- Report Date
- May 12, 2014
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P950024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH THRESHOLDS AND LOW IMPEDANCE. THE LEAD WAS EXPLANTED. A NEW LEAD WAS IMPLANTED IN THE LEFT VENTRICLE AND CONNECTED TO THE RV PORT OF THE DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335188 | CAPSUREEPI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 4965-15 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00007 MO | Hospitalization| R | ADDRS1 IPG |