FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 4162549
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12712
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 7, 2014
- Report Date
- August 8, 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 THE PATIENT EXPERIENCED PAIN POST IMPLANT. A MICROPERFORATION DUE TO MICRODISLODGEMENT OF THE ATRIAL LEAD HAD OCCURRED. THE LEAD WAS REPOSITIONED AND 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 |
|---|---|---|---|---|---|---|---|
| 644147 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | Hospitalization| R | DTBA1D4 ICD, 6935 LEAD, 4194 LEAD |