FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3160360
·
Received June 10, 2013
Report
- Report Number
- 2649622-2013-08002
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- April 26, 2013
- Report Date
- April 26, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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: 4396 LEFT VENTRICULAR (LV) LEAD (B)(6) 2013; 6935M IMPLANTABLE TACHY LEAD (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING SEVERAL INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. IT WAS NOTED ON THE REMOTE TRANSMISSION, THERE WAS UNDER SENSING ON THE ATRIAL LEAD. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259895 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | D314TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |