BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3863730 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11268
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    March 31, 2014
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3998, LOT# V013615, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REPLACEMENT DONE (B)(6) 2014. THE REASON FOR REPLACEMENT WAS NOT GIVEN. RIGHT AFTER IT WAS REPLACED, IT WAS REPORTED THAT IT WASN¿T HOOKING UP RIGHT TO HER LEADS. THE PATIENT HAD A REVISION ON (B)(6) 2014 WHERE FLUID WAS FOUND AROUND THE STIMULATOR AND WAS DRAINED. IT WAS STATED THAT THE STIMULATOR WAS PULLED CLOSER TO THE SURFACE OF HER ABDOMEN. IT WAS FURTHER REPORTED THAT THE EXTENSION WAS TWISTED BY HAND IN THE PATIENT¿S ABDOMEN, AS SHE WAS A LARGE PATIENT AND PLAYED WITH IT. THE EXTENSION WAS REPLACED DURING THE (B)(6) 2014 REVISION AND EVERYTHING WAS FINE. THE PATIENT LEFT HAPPY. IT WAS FURTHER REPORTED THAT THE CAUSE OF THE LEAD/EXTENSION NOT HOOKING UP CORRECTLY WAS NOT DETERMINED. IT WAS FURTHER REPORTED THAT WHEN THE EXTENSION WAS REPLACED, THE FLUID THAT WAS DRAINED WAS TESTED FOR INFECTION, WHICH WAS STATED TO BE FINE. IT WAS FURTHER REPORTED THAT IMPEDANCES WERE OFF "SOMETIME IN (B)(6)." NUMEROUS ATTEMPTS HAVE BEEN MADE FOR FOLLOW UP INFORMATION. IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEADS WERE PLACED INTO THE IMPLANTABLE NEUROSTIMULATOR (INS) IN THE CORRECT MANNER AND THE IMPEDANCE CHECK YIELDED ACCEPTABLE READINGS. THE INS POCKET WAS CLOSED AFTER THE IMPEDANCE TEST. IT WAS FURTHER REPORTED THAT ON (B)(6) 2014 THE PATIENT'S IMPEDANCES WERE NOTED TO BE HIGH. THE DOCTOR DECIDED TO REPLACE THE DEVICE AT THAT TIME AND SET UP A LEAD REVISION FOR A LATER DATE. ON (B)(6) 2014 THE PATIENT WAS SEEN BY A MANUFACTURER REPRESENTATIVE AND THE IMPEDANCES WERE STILL HIGH. ON (B)(6) 2014 THE PATIENT HAD A LEAD REVISION. AFTER THE REVISION THE PATIENT REPORTED GOOD COVERAGE FROM THEIR STIMULATOR. THE REPRESENTATIVE THOUGHT THAT THE PATIENT WAS DOING GREAT AND HAD GOOD COVERAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339871 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention