BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3904939 · Received July 1, 2014

    Report

    Report Number
    3004209178-2014-12319
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 11, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    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: 3550-29, LOT# N455694, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MRI WAS NEVER DONE BECAUSE THE DOCTOR REMOVED/EXPLANTED THE WHOLE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM. THERE WERE NO DEVICE MALFUNCTIONS NOTED. IT WAS NOTED THAT THE PATIENT JUST DID NOT GET ENOUGH RELIEF. THE PATIENT WAS DOING OKAY AND WAS STILL IN A BIT OF PAIN BUT WAS ON MEDICATION FOR THAT. THE PATIENT WAS NOT ON THE CALENDAR FOR ANY FUTURE APPOINTMENTS.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED BY THE HEALTHCARE PROFESSIONAL (HCP) THAT THIS WAS A PATIENT WITH A TRAUMATIC BRAIN INJURY AND VULVODYNIA. IT WAS NOTED THAT THERE WERE RETROGRADE LEADS PLACED AND THEY WERE "DIFFICULT TO PASS." IT WAS NOTED THAT THERE WAS A SMALL "POKE HOLE" DUROTOMY AT L5/S1 PATCHED WITHOUT INCIDENT. IT WAS NOTED THAT THERE WAS NO FURTHER LEAK. IT WAS NOTED THAT THE STIMULATOR WAS TURNED OFF A FEW DAYS POSTOPERATIVELY WHEN THE PATIENT COULD NOT URINATE/VOID AT THE UROLOGIST'S OFFICE. AN MRI WAS ORDERED BUT NOT PERFORMED AS THE DEVICE WAS REMOVED FIRST WITH EARLY INFECTION NOTED AT THE BATTERY SITE BUT NOT THE LAMINECTOMY SITE. THE EXPLANT DATE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WAS (B)(6) 2014. THE CAUSE OF EVENT WAS NOT DETERMINED. IT WAS UNKNOWN IF IT WAS DEVICE RELATED. IT WAS NOTED THAT REPROGRAMMING WAS NEEDED. IT WAS NOT KNOWN IF THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. IT WAS ALSO NOTED THAT THE PATIENT WAS NOT RECOVERED AND THE SYMPTOMS/ISSUE WAS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NOT BEEN ABLE TO RELIEVE THEIR BLADDER. IT WAS NOTED THE PATIENT¿S HEALTHCARE PROVIDER HAD TO IMPLANT A CATHETER. IT WAS REPORTED THE PATIENT FELT SHARP PAINS UP THEIR SPINE WHEN THEY TURNED THEIR HEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS TREATED WITH ANTIBIOTICS TO TREAT THE INFECTION AND SINCE THE ANTIBIOTICS THE PATIENT IS NOW DOING FINE AND THE INFECTION HAS CLEARED. THE PATIENT WAS ALSO REPORTED TO NOW BE ABLE TO VOID AND HAS NO MORE ISSUES WITH URINARY RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383751 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention