FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2954575
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-02339
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- September 15, 2012
- Report Date
- December 19, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT VENTRICULAR HIGH RATE (VHR) EPISODE SHOWED NON-PHYSIOLOGICAL VENTRICULAR OVERSENSING WHICH LOOKED LIKE NOISE AND WAS CAUSING INHIBITION. CAPTURE MANAGEMENT ALSO SHOWED CHRONIC HIGH THRESHOLDS. THE RIGHT VENTRICULAR (RV) 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 |
|---|---|---|---|---|---|---|---|
| 58192 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5054-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | ADDR01 IMPLANTABLE PULSE GENERATOR |