FDA Adverse Event
Malfunction
Summary report: N
CAPSURE Z NOVUS
MDR report key: 2951967
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00330
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Report Date
- November 7, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089/S38
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT: 5054 IMPLANTABLE PACING LEAD (B)(6) 2006.(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CAPTURE THRESHOLD HAS RISEN ON THE ATRIAL LEAD. 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 |
|---|---|---|---|---|---|---|---|
| 57443 | CAPSURE Z NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5554-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ADDRL1 IMPLANTABLE PULSE GENERATOR |