FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 2952130
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00428
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 13, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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: 4568, IMPLANTABLE PACING LEAD, (B)(6) 2003. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) BIPOLAR LEAD SENSING DROPPED AND WAS CAUSING INTERMITTENT UNDERSENSING. IT WAS ALSO NOTED THE BIPOLAR IMPEDANCE HAS DROPPED. THE DEVICE WAS REPROGRAMMED TO UNIPOLAR AND THE LEAD 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 |
|---|---|---|---|---|---|---|---|
| 56793 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4068-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00086 YR | Required Intervention | ADDR01 IMPLANTABLE PULSE GENERATOR |