FDA Adverse Event
Malfunction
Summary report: N
CAPSURE
MDR report key: 2951442
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00111
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 3, 2012
- Report Date
- November 3, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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. PRODUCT: 4074 IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS ATRIAL UNDER SENSING FOUND ON THE REMOTE PACEMAKER TRANSMISSION. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56994 | CAPSURE | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 457445 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | SEDR01 IMPLANTABLE PULSE GENERATOR (IPG) |