BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 8623700 · Received May 20, 2019

    Report

    Report Number
    3004209178-2019-09884
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    March 30, 2012
    Report Date
    June 5, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED ON (B)(6) 2013. THE PATIENT DEVELOPED DRAINAGE FROM HER LEAD WHICH WAS OBVIOUSLY INFECTED. THE PATIENT FAILED TO RESPOND TO ORAL ANTIBIOTICS. THE PATIENT TOLERATED THE SYSTEM REMOVAL WELL AND THE PATIENT RETURNED TO THE RECOVERY ROOM IN STABLE AND SATISFACTORY CONDITION. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. INFORMATION WAS REPORTED THAT THE PATIENT HAD A (B)(6) INFECTION ((B)(6)). THE PATIENT STATED THAT HER SPINAL CORD STIMULATOR (SCS) BATTERY HAD FLIPPED "NOT EVEN 3 MONTHS AFTER THE SURGERY (CONFIRMED SOMETIME IN 2012), SO THEY WENT TO FLIP IT BACK IN (B)(6) 2012 AND THEN THEY FLIPPED IT BACK. THEN IN (B)(6) OR EARLY (B)(6) THE PATIENT ENDED UP WITH AN ABSCESS AND (B)(6) SO THEY TOOK IT OUT". THE PATIENT SAID THE ABSCESS AND (B)(6) WAS FIRST FOUND "TOWARDS THE END OF (B)(6) OR EARLY (B)(6) IN 2013 AND THE PATIENT HAD TO GO TO THE ER BECAUSE OF THE ABSCESS. THE PATIENT SAID THE INS WAS THEN TAKEN OUT AT THIS TIME, AGAIN STATING "THE END OF (B)(6) OR INTO THE FIRST WEEK IN (B)(6) 2013. THE PATIENT HAD THEIR FULL SYSTEM EXPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416696 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention