FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX MRI SURESCAN
MDR report key: 4162815
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12598
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- July 25, 2014
- Report Date
- August 1, 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
- 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) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE 21 VENTRICULAR TACHYCARDIA (VT) DETECTIONS DUE TO RIGHT VENTRICULAR (RV) LEAD T-WAVE OVERSENSING (TWOS). THE RV LEAD SENSITIVITY WAS DECREASED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THIS PATIENT IS PART OF (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639219 | 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 | 00075 YR | Required Intervention | RVDR01 IPG |