FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3051195
·
Received April 10, 2013
Report
- Report Number
- 2649622-2013-04824
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Report Date
- November 13, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 DEVICE: 5092-58, (B)(6) 2003. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET STIMULATION. IT WAS NOTED THAT THERE WAS ATRIAL POLARITY SWITCH DURING THE PATIENT'S LAST VISIT AND NOW THERE IS A POLARITY SWITCH ON THE VENTRICULAR LEAD. IT WAS NOTED THERE WERE MULTIPLE LOW IMPEDANCE COUNTS WHICH CAUSED THE 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 |
|---|---|---|---|---|---|---|---|
| 153064 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR | ADDR01 IMPLANTABLE PULSE GENERATOR |