BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORESENSOR MRI

    MDR report key: 4181495 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19907
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 26, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-29, LOT# N142068, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    INTERVENTION REQUIRED NO LONGER APPLIES TO THIS EVENT. MANUFACTURER RECORDS INDICATE THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2014 BUT ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2014. (B)(4). SERIOUS INJURY NO LONGER APPLIES TO THIS EVENT. MALFUNCTION IS APPLICABLE TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNING OFF WHEN HER PROGRAMMER TUNED ITSELF OFF. IT WAS CONFIRMED THAT THE IMPLANT WAS ON MULTIPLE TIMES (WHEN CONNECTING PATIENT PROGRAMMER TO INS). IT WAS ADVISED FOR THE PATIENT TO BRING HARDWARE FOR THE FIRST FOLLOW UP AFTER IMPLANT ON (B)(6). THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT NOTICED PAIN IN HER FOOT THE DAY OF THE REPORT. THE PATIENT DIDN¿T FEEL STIMULATION VERY MUCH, BUT WAS INSTRUCTED ON HOW TO INCREASE STIMULATION. IT WAS LATER REPORTED THAT THERE WAS A 50% OR GREATER SYMPTOMS REDUCTION. THE INS WAS THE COMPONENT INVOLVED IN THE EVENT, AND THE BATTERY WOULDN¿T HOLD CHARGE. TROUBLESHOOTING THAT WAS DONE WAS REPROGRAMMING AND EVALUATION, THEN SURGERY TO REPLACE THE INS. IT WAS UNKNOWN IF THE CAUSE WAS DEVICE RELATED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAS NOT HAD ANY MORE PROBLEMS SINCE THE BATTERY REPLACEMENT IN SEPTEMBER. THE MANUFACTURER REPRESENTATIVE DID NOT HAVE SERIAL NUMBER INFORMATION, AND STATED THE DATE OF THE REPLACEMENT WAS (B)(6) 2014. THIS DEVICE WAS NOT EXPLANTED. PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2014-21894 FOR INFORMATION REGARDING THE EXPLANTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660035 RESTORESENSOR MRI STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention