FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 2953361
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-01081
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Report Date
- November 20, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. CONCOMITANT PRODUCT: CONCOMITANT PRODUCT: 4512 IMPLANTABLE PACING LEAD 1989 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD SOME INCREASE IN CAPTURE THRESHOLDS BUT THEY HAVE STABILIZED. THE RV 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 |
|---|---|---|---|---|---|---|---|
| 55547 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | (B)(4) IMPLANTABLE PULSE GENERATOR |