BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5406623 · Received February 3, 2016

    Report

    Report Number
    3004209178-2016-01411
    Event Type
    Injury
    Date Received
    February 3, 2016
    Date of Event
    October 16, 2015
    Report Date
    April 11, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MRI BURN ISSUE WAS PREVIOUSLY REPORTED (REGULATORY REPORT #3004209178-2016-01409); HOWEVER ADDITIONAL INFORMATION STATES THE ISSUE WAS NOT DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INS (SERIAL # (B)(4)) WAS RETURNED AND ANALYSIS FOUND THE INS GROMMET TO BE LOOSE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED VIA THE MANUFACTURER REPRESENTATIVE THERE WAS BATTERY SHOCKING WHEN WALKING AROUND AND STILL FELT IT EVEN AFTER THE ADAPTIVESTIM WAS TURNED OFF. THE ISSUE WAS IDENTIFIED WHEN THE PATIENT CAME IN FOR A REPROGRAM AND DESCRIBED THE SHOCKING FEELING AS "GETTING ZAPPED". THE IMPEDANCES WERE CHECKED AND ALL WERE WITHIN NORMAL RANGE. THE PATIENT WAS SCHEDULED FOR A BATTERY REPLACEMENT TO SEE IF THAT WOULD SOLVE THE ISSUE. AN XRAY WAS TAKEN AND SHOWED THE LEAD HAD ONLY MIGRATED DOWN 2 ELECTRODES. SURGICAL INTERVENTION WAS PLANNED, BUT WAS NOT SCHEDULED; HOWEVER, IT WAS ALSO STATED THE PATIENT WAS SCHEDULED FOR A BATTERY REPLACEMENT TO SEE IF THAT WOULD SOLVE THE ISSUE.. THE PATIENTMEDICAL HISTORY SHOWED THE PATIENT WAS BURNED BY AN MRI MACHINE DURING A SCAN. THE PATIENT OUTCOME WAS REPORTED TO BE ALIVE WITH NO INJURY. THE INDICATION FOR THERAPY WAS LUMBAR RADICULOPATHY AND SPINAL PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEADS WERE NOT REPLACED BUT THE INS WAS REPLACED ON (B)(6) 2016. THE PATIENT WAS GETTING SOME SHOCKING AT HOME; THE DOCTOR BELIEVED THAT IT WAS DUE TO SOME ELECTROMAGNETIC INTERFERENCE. NO DIAGNOSTICS WERE DONE BY DOCTOR TO REACH THAT "GUESS". DOCTOR DECIDED TO REPLACE THE BATTERY TO RESOLVE THE SHOCKING ISSUE. THE BATTERY HAD BEEN RETURNED BY REP FOR ANALYSIS JUST TO MAKE SURE THERE WERE NO DEVICE ISSUES. THE MRI BURN (REGULATORY REPORT #3004209178-2016-01409) WAS UNRELATED TO DEVICES AS IT OCCURRED A LONG TIME BEFORE THE PATIENT HAD THE DEVICES IMPLANTED. PATIENT HAD PAIN DUE TO THAT BURN; THEREFORE, THE SCS SYSTEM WAS IMPLANTED FOR THE PAIN. THE REPRESENTATIVE HAD NOT NOT HEARD ANYTHING FROM THE HCP OR THE PATIENT SINCE THE INS REPLACEMENT ASSUMING EVERYTHING IS FINE. THE PATIENT DID HAVE A FOLLOW UP APPOINTMENT IN NEXT COUPLE OF WEEKS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65745 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention