FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3062197
·
Received April 16, 2013
Report
- Report Number
- 2649622-2013-05120
- Event Type
- Malfunction
- Date Received
- April 16, 2013
- Report Date
- February 27, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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. CONCOMITANT PRODUCT: 4092 IMPLANTABLE PACING LEAD (B)(6) 2006. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD HAD INCREASED THRESHOLDS AND HIGH IMPEDANCE THAT HAD BEEN RISING SINCE IMPLANT. THE LEAD IS STILL 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 |
|---|---|---|---|---|---|---|---|
| 163948 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | P1501DR IMPLANTABLE PULSE GENERATOR |