FDA Adverse Event
Malfunction
Summary report: N
CAPSURE Z NOVUS
MDR report key: 3152579
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06757
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Report Date
- April 22, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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. CONCOMITANT PRODUCTS: 5054-58 IMPLANTABLE PACING LEAD, (B)(6) 2002. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE ON BOTH LEADS, ALONG WITH HIGH ATRIAL THRESHOLD. THE LEADS 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 |
|---|---|---|---|---|---|---|---|
| 252084 | CAPSURE Z NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5554-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR | (B)(4) IMPLANTABLE PULSE GENERATOR |