FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3153408
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05991
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 14, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON THE PATIENT'S PRE-HOSPITAL DISCHARGE CHECK, IT WAS FOUND THE ATRIAL LEAD HAD DISLODGED AND DROPPED ACROSS HE VALVE INTO THE RIGHT VENTRICLE. CHEST X-RAY CONFIRMED LEAD DISLODGEMENT. THE 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 |
|---|---|---|---|---|---|---|---|
| 259089 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Hospitalization| R |