FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX MRI SURESCAN
MDR report key: 3991788
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-07950
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 14, 2014
- Report Date
- May 15, 2014
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
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. PRODUCTS: (B)(4) LEAD IMPLANTED: 2014 (B)(6). (B)(4).
Description of Event or Problem · 1
THE PATIENT REPORTED THAT ONE OF THEIR LEADS WAS NOT WORKING CORRECTLY. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) BECAME DISLODGED, AND UNABLE TO CAPTURE AT MAXIMUM OUTPUT. THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE RV LEAD WAS REPOSITIONED, AND 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 |
|---|---|---|---|---|---|---|---|
| 467866 | 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 | 00087 YR | Hospitalization| L| R | A2DR01 IPG |