FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 3152394
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06811
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- April 16, 2013
- Report Date
- April 23, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 PRODUCTS: 5568 IMPLANTABLE PACING LEAD IMPLANTED: 2003 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED OUT OF RANGE IMPEDANCE WHICH TRIGGERED A LEAD WARNING AND A POLARITY SWITCH. 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 |
|---|---|---|---|---|---|---|---|
| 253008 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5068-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00048 YR | (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) |