FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2951696
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00176
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 5, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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: 4194 IMPLANTABLE PACING LEAD, (B)(6) 2008, 6947 IMPLANTABLE DEFIBRILLATOR LEAD (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A DIAGNOSIS OF BACTEREMIA FROM A CULTURE TAKEN FROM THE DEVICE POCKET. THE DEVICE AND LEADS WERE EXPLANTED AND THE PATIENT WAS GIVEN ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55692 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Hospitalization| R | D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |