BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 7102227 · Received December 8, 2017

    Report

    Report Number
    3004209178-2017-25696
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    November 3, 2017
    Report Date
    January 29, 2018
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 39286-65, SERIAL# (B)(4), 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR LUMBAR RADICULOPATHY AND SPINAL PAIN. INTERMITTENT STIMULATION WAS REPORTED. REP WAS HOPING TO SEE THE PATIENT ON 2017-DEC-06. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT'S THERAPY WAS INTERMITTENT, PATIENT COULD MOVE THE INS IN THE POCKET TO GET THERAPY, BUT NOW THERAPY IS NONEXISTENT. CALLER RAN IMPEDANCES AT 3V: 01 25515 02 32700 03 28024 04 >40K 05 34582 06 25107 07 19732 08 >40 09 39246 10 >40 11 27776 12 40K 13 14060 14 40K 15 17925. THE CALLER STATED THAT THEY HAVE AN X-RAY OF THE LEAD AND IT APPEARS TO LOOK FINE. REVIEWED TO CHECK THE HEADER TO SEE HOW THAT APPEARS. THE CALLER STATED NO FALLS OR TRAUMA, NO SHOCKING OR JOLTING. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION: IT WAS REPORTED THE X-RAY WAS UNABLE TO VISUALIZE LEADS GOING INTO THE HEADER BLOCK, BUT NO ELECTRODES WERE VISUALIZED OUTSIDE OF THE HEADER BLOCK. SUSPECTED LEAD FRACTURE AT ENTRY INTO HEADER BLOCK. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THE CAUSES OF HIGH IMPEDANCES AND LEAD FRACTURE WERE UNKNOWN. AWAITING TO SPEAK WITH THE MANAGING PHYSICIAN SO HE CAN DECIDE A PLAN OF ACTION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE CIRCUMSTANCES THAT LED TO THE ISSUES WERE THAT THE UNIT STOPPED WORKING; CONTROLS SAID ON BUT COULD NOT FEEL ANYTHING ON ANY SETTING. PATIENT CONTACTED THE REP AND MET WITH THEM AT HCP OFFICE. REP SAID THEY COULD NOT SEE WIRES ATTACHED TO THE POCKET DEVICE. THE ISSUE WAS NOT RESOLVED. THE REP SAID MAYBE WIRES CAN BE REATTACHED OR NEW DEVICE (MORE UPDATED) COULD BE PUT IN BUT DID NOT KNOW IF ANYONE AROUND THAT AREA COULD DO THAT. PATIENT PROVIDED HCP INFO AND THEIR WEIGHT INFORMATION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880836 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 68 YR