FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 6163648
·
Received December 9, 2016
Report
- Report Number
- 2649622-2016-15746
- Event Type
- Malfunction
- Date Received
- December 9, 2016
- Date of Event
- September 24, 2016
- Report Date
- September 24, 2016
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: 419688 LEAD, IMPLANTED: (B)(6) 2011, 694765 LEAD, IMPLANTED: (B)(6) 2008. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON EPISODE ELECTROCARDIOGRAMS (EGM). THERE WERE ALSO CHRONIC LOW AMPLITUDE P WAVES. 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 |
|---|---|---|---|---|---|---|---|
| 814445 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | D334TRG ICD |