BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4021403 · Received August 19, 2014

    Report

    Report Number
    3004209178-2014-15547
    Event Type
    Injury
    Date Received
    August 19, 2014
    Report Date
    July 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DOCTOR HAD TO REMOVE THE ENTIRE SPINAL CORD STIMULATOR (SCS) SYSTEM. THE SCS SYSTEM WASN¿T WORKING ON THE RIGHT SIDE OF THE PATIENT¿S BODY WHERE MOST OF THEIR PAIN WAS. AN X-RAY WAS TAKEN WHICH SHOWED THAT THE LEAD HAD DROPPED 3-4 INCHES. IT WAS UNKNOWN WHY THE LEAD DROPPED BUT IT WAS THOUGHT THAT IT WAS A BAD TIME FOR IT TO BE IMPLANTED BECAUSE THE PATIENT WAS MOVING. THE PATIENT DIDN¿T DO ANY LIFTING OR BENDING BUT WAS MORE ACTIVE AND IT MIGHT HAVE BEEN THE PATIENT¿S FAULT THAT THE LEAD FELL. THE DOCTOR TRIED TO REPLACE THE LEAD ON 2014-(B)(6) BUT THEY COULDN¿T GET THROUGH THE SCAR TISSUE SO THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6). THE SCAR TISSUE WAS DUE TO A PREVIOUS BACK SURGERY. THE PATIENT HAD AN APPOINTMENT ON (B)(6) TO DISCUSS IMPLANTING A NEW LEAD. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497917 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention