FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 4162608
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12678
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 28, 2014
- Report Date
- August 28, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 PATIENT'S RIGHT ATRIAL (RA) LEAD BECAME DISLODGED AND NOW RESIDES IN THE RIGHT VENTRICLE. THE DISLODGEMENT AND CURRENT POSITION WAS CONFIRMED WITH DIAGNOSTIC IMAGES. THE PATIENT WAS REPROGRAMMED WITH ATRIAL PACING THERAPY TURNED OFF AND THE LEAD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 644336 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Required Intervention | 5076-58 LEAD, SEDR01 ICD |