FDA Adverse Event
Injury
Summary report: N
TBD
MDR report key: 2955436
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-01360
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- November 6, 2012
- Report Date
- November 7, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061/S034
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, 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 DAY AFTER IMPLANT THE THRESHOLD ON THE ATRIAL LEAD WAS HIGH. 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 |
|---|---|---|---|---|---|---|---|
| 58996 | TBD | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 457453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00043 YR | Hospitalization| R | 6947M IMPLANTABLE TACHY LEAD |