FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 17517440
·
Received August 11, 2023
Report
- Report Number
- MW5124389
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Report Date
- September 1, 2011
- Manufacturer
- MEDTRONIC
- Product Code
- DTB
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THIS RV LEAD WAS IMPLANTED ON (B)(6) 2005. A CALL TO TECHNICAL SERVICES ON 7/26/11 STATES THAT A HALTER SHOWED 1400MS BETWEEN R-WAVES. REP THINKS IT MIGHT BE OVERSENSING IN V. PATIENT GOES IN AND OUT OF A-V CONDUCTION. HISTOGRAMS SHOW SENSING IN 50S. TS DISCUSSED MODIFIED ATRIAL BASED TIMING WHICH COULD RESULT IN RATES IN THE 50S (LRL SET TO 60). CALLER CONCERNED BECAUSE SEEING AP VS THEN 1200MS BEFORE NEXT AS. LRL IS 60 AND AVD IS 300MS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2192657 | CAPSUREFIX NOVUS | PERMANENT PACEMAKER ELECTRODE | DTB | MEDTRONIC | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |