FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX MRI SURESCAN
MDR report key: 3993463
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09312
- Event Type
- Injury
- Date Received
- August 8, 2014
- Report Date
- May 23, 2014
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- 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. PRODUCTS: RVDR01 IPG IMPLANTED: 2013 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPEDANCE HAD INCREASED. THE RIGHT VENTRICULAR LEAD WAS FOUND TO BE DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471563 | CAPSUREFIX MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR | Hospitalization| R | (B)(4) LEAD |