CAPSUREFIX NOVUS
Report
- Report Number
- 2649622-2014-09909
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 24, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED A LEAD IMPEDANCE OUT OF RANGE ALERT. THE ANALYST NOTED AN OUT OF TREND SUBTHRESHOLD LEAD IMPEDANCE ALERT OCCURRED ON (B)(6) 2014. THE MAX ATRIAL PACE IMPEDANCE ROSE FROM 399 OHMS ON (B)(6) 2014 TO GREATER THAN 4000 OHMS THE WEEK ENDING (B)(6) 2014.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: (B)(4) ICD IMPLANTED: 2013 (B)(6). (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT AN ALERT WAS TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO A PACING IMPEDANCE OF GREATER THAN 3000 OHMS. PROVOCATIVE TESTING REVEALED THE RIGHT ATRIAL (RA) LEAD IMPEDANCES ARE UNSTABLE AND PRODUCED SENSING NOISE. THE RV AND RA LEAD CURRENTLY REMAIN 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 |
|---|---|---|---|---|---|---|---|
| 467338 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00083 YR | 694458 LEAD |