BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4243975 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21349
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    September 1, 2014
    Report Date
    March 3, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED A LOSS OF THERAPY AND A RETURN OF SYMPTOMS THAT COULD HAVE BEEN RELATED TO A FALL. THE PATIENT CHECKED THE DEVICE WITH THE PATIENT PROGRAMMER. TURNING THE STIMULATION ON DID NOT RESOLVE THE ISSUE. THE PATIENT HAD THE ABILITY TO CHANGE STIMULATION. IT WAS NOTED THE PATIENT'S PAIN GRADUALLY MIGRATED AND RETURNED. IT WAS IN THE NECK AND NOW IT WAS IN THE RIBS AND UNDER ARM. THE PATIENT FIRST HAD A FALL IN SEPTEMBER 2014 WHERE SHE NOTICED A POP AND SHE HAD HER HEALTHCARE PROVIDER (HCP) AND MANUFACTURER'S REPRESENTATIVE (REP) CHECK THE IMPLANTABLE NEUROSTIMULATOR (INS) AND SOMEONE TOLD HER IT WAS OK AND ANOTHER PERSON TOLD HER THE STITCHES POPPED. SINCE THE FALL, THE PATIENT ALSO HAD A HARD TIME RECHARGING THE INS AS IT BECAME TILTED AFTER THE FALL AND IT TOOK HOURS. GRADUALLY THE PAIN IN THE NECK MOVED AND NOW SHE HAD PAIN OR SPASMS IN HER RIBS AND UNDERARM. THE PATIENT NOTED SHE COULD NOT LEAVE THE INS ON FOR A LONG TIME (1-2) WEEKS BECAUSE IT GRABBED AHOLD OF HER NERVE AND IRRITATED IT AND SHE DID NOT LIKE THE FEELING. ANOTHER FALL WAS NOTED WHERE THE INS HIT THE FRONT OF THE DISHWASHER AND IT DENTED THE FRONT OF THE DISHWASHER. AN MRI OF THE SHOULDER WAS GOING TO BE TAKEN OF THE SHOULDER. THERE WAS POOR COMMUNICATION AND NO CONNECTION WITH THE PATIENT PROGRAMMER. COMMUNICATION WAS NOT POSSIBLE WITH THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR). IT WAS NOTED THE PATIENT DID NOT USE THE INS ALL THE TIME. THE PATIENT SHUT OFF THE INS A WEEK PRIOR TO THIS REPORT AND IT TOOK AN HOUR TO SYNC WITH THE INS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN SEPTEMBER 2014 THE PATIENT TOOK A FALL AND COULD FEEL THE BATTERY WAS ¿ALL TWISTED WELL NOT TWISTED, OR I COULD FEEL THE BATTERY ANYWAYS¿. IT WAS NOTED THAT THEIR CHARGE WAS NOT REALLY HOLDING AND SHE DID GO THROUGH BATTERIES ON HER PROGRAMMER A LOT FASTER SINCE THE FALL IN SEPTEMBER. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TOOK A HARD FALL IN SEPTEMBER AND SHE COULD FEEL A LOT OF PAIN AT THE INS SITE, AND SOMETIMES AFTER THAT SHE HAD AN ADJUSTMENT BY ONE OF THE MANUFACTURER REPRESENTATIVES AND WAS TOLD THAT IT MOVED, PULLED STITCHES AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THE PATIENT THOUGHT IT WAS STILL MOVING. THE PATIENT ALSO HAD POOR COVERAGE BEFORE THE FALL BUT AFTER THE FALL HAD NOTHING. THE PATIENT HAD BEEN GOING TO PHYSICAL THERAPY SINCE APRIL. THE PATIENT WONDERED IF THEY NEEDED TO HAVE X-RAYS PRIOR TO HAVE ANY REVISION AND IF THE INS WOULD CONTINUE TO MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725626 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention "SEE H10...."