FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 4830914
·
Received June 10, 2015
Report
- Report Number
- 2649622-2015-05647
- Event Type
- Injury
- Date Received
- June 10, 2015
- Date of Event
- April 7, 2015
- Report Date
- April 7, 2015
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
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: 439688 LEAD IMPLANTED ON (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM AN UNKNOWN LEAD. REPROGRAMMING WAS CONDUCTED. THE RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD ALL 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 |
|---|---|---|---|---|---|---|---|
| 374090 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | Required Intervention | 693558 LEAD, D334TRG ICD |