FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 4830139
·
Received June 10, 2015
Report
- Report Number
- 2649622-2015-06273
- Event Type
- Injury
- Date Received
- June 10, 2015
- Report Date
- April 3, 2015
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. ANALYSIS INDICATED THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. 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 DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED WITH NO REASON PROVIDED FOR THE EXPLANT. THE DEVICE WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377287 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |