FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2955456
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-01431
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- December 4, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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: 5076 IMPLANTABLE PACING LEAD (B)(6) 2006. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAD BEEN GRADUALLY RISING AND HAD STARTED AROUND 499 OHMS AND WAS NOW AT 1458 OHMS BIPOLAR AND 1200 OHMS UNIPOLAR. ALSO THE R-WAVES WERE 2-2.8 MILLIVOLTS BIPOLAR AND 4-5.6 MILLIVOLTS UNIPOLAR. THE RV LEAD WAS PROGRAMMED TO UNIPOLAR SENSING AND BIPOLAR PACING. THE RV LEAD WILL CONTINUE TO BE MONITORED CLOSELY AND 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 |
|---|---|---|---|---|---|---|---|
| 58226 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR | Required Intervention | SDR303B IMPLANTABLE PULSE GENERATOR |