BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3603459 · Received February 3, 2014

    Report

    Report Number
    3004209178-2014-01477
    Event Type
    Injury
    Date Received
    February 3, 2014
    Date of Event
    December 1, 2013
    Report Date
    May 11, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 9565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE LAST TIME THE PATIENT WAS REPROGRAMMED THE STIMULATION WAS A LITTLE CLOSER TO BEING IN THE PATIENT¿S LOWER BACK AND WAS ¿STILL IN HER LEGS MORE THAN LOWER BACK.¿ THE PATIENT REPORTED SHE BELIEVED HER STIMULATION WAS ¿GETTING CLOSER.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 MONTHS PRIOR TO REPORT THE PATIENT HAD A LEAD REVISION. IT WAS NOTED THAT AT THE TIME OF REPORT ¿IT¿S DOING OK BUT COULD BE BETTER.¿ IT WAS REPORTED THAT THE PATIENT¿S PAIN IS IN THEIR LOWER BACK AND BUTTOCKS HOWEVER THEY CANNOT GET THE ZAPPING (STIMULATION) IN THEIR LOWER BACK. IT WAS REPORTED THE STIMULATION WAS IN THEIR UPPER LEGS AND A ¿LITTLE IN THEIR BUTTOCKS.¿ IT WAS NOTED THE PATIENT¿S DEVICE IS A ¿PAIN IN THE BUTT¿ TO CHARGE AND EVEN WHEN THEY SHUT THE DEVICE OFF IT TAKES ¿ALL DAY TO CHARGE.¿ **INFORMATION OMITTED PERTAINING TO RELATED EVENT (B)(4) ¿ ZAPPING SENSATION**

    Description of Event or Problem · 1

    THE CONSUMER ADDITIONALLY REPORTED THAT THE PATIENT USED THE DEVICE VERY LITTLE CAUSE IT ZAPPED MORE IN THEIR LEGS THAN LOWER BACK. AFTER A WHILE THE PATIENT QUIT USING IT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. THE INDICATION FOR USE INCLUDED CHRONIC LOW BACK PAIN AND SPINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70091 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention