FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3992833
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09636
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 12, 2014
- Report Date
- May 12, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. PRODUCTS: 6935M55 LEAD IMPLANTED: 2014 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPEDANCE ON THE RIGHT ATRIAL (RA) LEAD HAS GONE FROM MID 400'S TO 1,200 OHMS RANGE WHERE IT HAS STABILIZED. THE LEAD REMAINS IN USE AND WILL BE CLOSELY MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471760 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00078 YR | (B)(4) ICD |