BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4609279 · Received March 17, 2015

    Report

    Report Number
    3004209178-2015-04836
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Date of Event
    February 24, 2015
    Report Date
    November 1, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3550-P4, LOT# N258756, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 365538, LOT# N220387, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT THE PATIENT FELL ON THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND ¿THREW IT OUT OF WHACK¿. THE PATIENT WENT TO THE ER AND THEIR LEGS WERE NUMB. IT WAS NOTED THAT THE PATIENT DID NOT HAVE A LOCAL PHYSICIAN TO FOLLOW UP WITH AT THE TIME OF REPORT. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR AN 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: INFORMATION WAS REPORTED THAT THE PATIENT HAD A NON-RECHARGEABLE INS IMPLANTED IN 2011 (WHICH CONTRADICTS THE IMPLANT DATE ON FILE), AND THERE WAS A "GROUND FAULT" ON THE BATTERY. PATIENT STATED "BOOM, IT JUST QUIT". PATIENT THINKS THE INS MAY HAVE BEEN DEFECTIVE. THE PATIENT ALSO STATED THAT THIS DEVICE WAS REMOVED IN (B)(6) 2015 BUT ALSO STATED THAT IT WAS REMOVED LAST YEAR, IN 2016. THE PATIENT ALSO STATED A MANUFACTURING REPRESENTATIVE (REP) WAS PRESENT WHEN THE BATTERY WAS REMOVED AND REPLACED BY CURRENT RECHARGEABLE INS. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182019 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention