BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1181767 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06230
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    April 2, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT STATED THAT SINCE IMPLANT, FOR THE FIRST 35-40 SECONDS, WHEN HE TURNED THE STIMULATOR EITHER ON OR OFF, HE FELT A SHOCKING THAT TRAVELED THROUGHOUT HIS HEAD AND THE REST OF HIS BODY. AFTER 35-40 SECONDS HE WAS FINE. THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT HAD EXPERIENCED THE SHOCKING SINCE HIS LAST PROGRAMMING SESSION WHEN THE STIMULATOR VOLTAGE WAS INCREASED FROM 3.0 TO 3.2 AND THE PULSE WIDTH WAS INCREASED FROM 90 TO 120; THE RATE REMAINED THE SAME AT 185. IMPEDANCE MEASUREMENTS WERE NORMAL; THOUGH ELECTRODES 0 AND 1 WITH CASE WERE BOTH 1484 OHMS. THE HCP DID NOT HAVE BIPOLAR IMPEDANCES. MOVEMENT DID CAUSE THE STIMULATION TO CHANGE. ANOTHER HCP REPORTED THAT THE PATIENT HAD FALLEN OUT OF BED SINCE THE REPROGRAMMING. THE STIMULATOR WAS REPROGRAMMED. THE VOLTAGE WAS DECREASED TO 2.6 VOLTS; PULSE WIDTH DECREASED TO 90, THE RATE STAYED THE SAME. THE PATIENT CONTINUED TO HAVE THE SHOCKING SENSATIONS. BIPOLAR IMPEDANCES WERE CHECKED AND READINGS OF >2000 OHMS WERE FOUND ON ALL OR SOME OF THE BIPOLAR PAIRS. THERAPY IMPEDANCES WERE 971 OHMS; CURRENT WAS 50. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| UNK CONVERSION TYPE: MODEL LEADN| IMPLANTED,