BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4234132 · Received November 7, 2014

    Report

    Report Number
    3004209178-2014-21117
    Event Type
    Injury
    Date Received
    November 7, 2014
    Report Date
    October 14, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 97791, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 97791, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL # (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE LEAD (SERIAL # (B)(4)) FOUND THAT THE STIMULATOR LEAD BODY HAD A BROKEN CONDUCTOR WITHIN 10 CENTIMETERS OF THE CONNECTOR AREA.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED. THE REASON FOR REMOVAL WAS NOT INDICATED TO HAVE BEEN DUE TO NORMAL BATTERY DEPLETION. IT REMAINS UNCLEAR WHAT THE REASON FOR REMOVAL WAS. THE FULL SYSTEM WAS REMOVED THE SAME TIME. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. FOLLOW-UP HAS BEEN INITIATED TO DETERMINE THE CAUSE OF THE EXPLANT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S BATTERY WAS REMOVED TO PERFORM ADEQUATE DECOMPRESSION PROCEDURE ON L1 AND L2. THE PATIENT HAD NOT BEEN USING THEIR DEVICE BECAUSE THEY WERE NOT GETTING ENOUGH RELIEF, ALTHOUGH THEY NEVER MENTIONED/ALLEGED ANY DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717281 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention