FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3993883
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09061
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- March 15, 2010
- Report Date
- June 26, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH IMPEDANCE. THE LEAD WAS PROGRAMMED OFF TO A VENTRICLE ONLY MODE AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469477 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR | Required Intervention | D224TRK ICD, 6947-65 LEAD, 4196-88 LEAD |