FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX MRI SURESCAN
MDR report key: 4162678
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12661
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Report Date
- July 26, 2014
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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: 5086MRI-45 LEAD, IMPLANTED: (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS NO CAPTURE. IT WAS NOTED THAT AT THE TIME OF THE INTERROGATION, THE PATIENT'S UNDERLYING RHYTHM WAS NORMAL SINUS RHYTHM. NO REPROGRAMMING WAS DONE AND THE LEAD 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 |
|---|---|---|---|---|---|---|---|
| 643919 | CAPSUREFIX MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00097 YR | RVDR01 IPG |