FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3152013
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-05565
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- February 15, 2013
- Report Date
- March 1, 2013
- 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. CONCOMITANT PRODUCTS: 4076 IMPLANTABLE PACING LEAD: (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD DISLODGED WITHIN A MONTH AFTER IMPLANT. IT WAS NOTED THAT THERE WAS TISSUE ON THE HELIX AND THE PHYSICIAN DECIDED TO REPLACE THE LEAD WITH A NEW RV LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253342 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00078 YR | Hospitalization| R | ADDRL1 IMPLANTABLE PULSE GENERATOR (IPG) |