FDA Adverse Event
Injury
Summary report: N
CAPSURE FIX MRI
MDR report key: 3153624
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06131
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 13, 2013
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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): (CONT) 5086MRI, IMPLANTABLE PACING LEAD, 2013-(B)(6); RVDR01, IMPLANTABLE PULSE GENERATOR, 2013-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT POST IMPLANT THE RIGHT ATRIAL (RA) LEAD WAS OBSERVED TO BE DISLODGED ON FLUOROSCOPY. THE POCKET WAS REOPENED AND THE LEAD WAS SUCCESSFULLY REPOSITIONED WITHOUT INCIDENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254376 | CAPSURE FIX MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Hospitalization| R |