FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX MRI SURESCAN
MDR report key: 3992947
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09588
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- April 19, 2013
- Report Date
- May 16, 2014
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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: 5086MRI45 LEAD, IMPLANTED: (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING "A LOT OF TWITCHES AND WEIRD FEELINGS". THE PATIENT WAS EXPERIENCING EXTRACARDIAC STIMULATION. THE RIGHT VENTRICULAR LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS ENROLLED IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472167 | 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 | 00068 YR | Required Intervention | A2DR01 IPG |