FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3153094
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05810
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 1, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2010. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN USED A SCALPEL TO CUT THE REMAINING SECTION OF THE CATHETER APART, AND THE SCALPEL CUT INTO THE INSULATION OF THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255238 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00030 YR | SEDR01 IMPLANTABLE PULSE GENERATOR (IPG) |