FDA Adverse Event
Injury
Summary report: N
CAPSURE SENSE
MDR report key: 3993030
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09531
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 16, 2014
- Report Date
- June 17, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 RIGHT ATRIAL (RA) LEAD DISLODGED AND WAS REPOSITIONED ONE DAY POST IMPLANT. IT WAS NOTED THAT THE LEAD WAS VERY DIFFICULT TO PLACE AT IMPLANT. THE LEAD IS STILL 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 |
|---|---|---|---|---|---|---|---|
| 468473 | CAPSURE SENSE | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 457453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Hospitalization| R | 4074 LEAD, ADDR01 IPG |