FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX MRI SURESCAN
MDR report key: 4830732
·
Received June 10, 2015
Report
- Report Number
- 2649622-2015-05899
- Event Type
- Injury
- Date Received
- June 10, 2015
- Date of Event
- April 24, 2015
- Report Date
- April 24, 2015
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD HAD FELL AFTER FOUR YEARS IMPLANTED AND EXHIBITED HIGH THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380506 | CAPSUREFIX MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | Hospitalization| R | RVDR01 IPG, 5086MRI52 LEAD |