BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 5477127 · Received March 3, 2016

    Report

    Report Number
    3004209178-2016-03837
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    January 23, 2016
    Report Date
    February 10, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377860, LOT# V005587, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V003916, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V003916, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V005587, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE PATIENT VIA THE MANUFACTURER¿S REPRESENTATIVE REPORTED THAT THEY FELT A SORENESS AT THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD SITE. AN IMPEDANCE CHECK SHOWED CONTACTS #6, 14, AND 15 WERE HIGH (>10,000 OHMS). NO SURGICAL INTERVENTIONS HAD OCCURRED OR WERE PLANNED. THE PATIENT WAS PROGRAMMED AROUND THE CONTACTS WITH HIGH IMPEDANCES. FOLLOW UP INFORMATION RECEIVED FEB. 9, 2016 FROM THE MANUFACTURER¿S REPRESENTATIVE REPORTED THAT THE PHYSICIAN EXAMINED THE AFFECTED AREAS AND STATED THEY DID NOT SEE ANY INFLAMMATION. IT WAS CONFIRMED THAT THE PATIENT WAS REPROGRAMMED AROUND THE 3 AFFECTED CONTACTS (6, 14, AND 15). THE PATIENT WAS TO BE SEEN BACK IN 4 WEEKS. THE INDICATION FOR USE FOR THE IMPLANTED DEVICE WAS NOTED AS NON-MALIGNANT PAIN. IF ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING POOR COMMUNICATION WITH THEIR PATIENT PROGRAMMER AND WAS UNABLE TO COMMUNICATE WITH THEIR RECHARGER (INSR), WHICH THEY DISCOVERED ON (B)(6) 2016. IT WAS REPORTED THAT IT HAD BEEN EIGHT MONTHS SINCE THEIR LAST SUCCESSFUL RECHARGE SESSION. THE PATIENT HAD NOT BEEN RECHARGING, BECAUSE THEY HAD SWELLING AT THEIR IMPLANT SITE AND THEIR HEALTHCARE PROVIDER ADVISED THEM NOT TO USE THEIR DEVICE. THE SWELLING BEGAN IN (B)(6) 2016. TROUBLESHOOTING FOR THE COMMUNICATION ISSUES WERE PERFORMED OVER THE PHONE, BUT ISSUES WERE UNRESOLVED. THE PATIENT WAS RECOMMENDED TO MEET WITH THEIR HEALTHCARE PROVIDER ABOUT A POSSIBLE OVERDISCHARGE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE CAUSE OF THE SWELLING WAS NOT KNOWN AND NO ADDITIONAL ACTIONS/INTERVENTIONS TOOK PLACE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THAT THE PATIENT WAS SENT TO GET AN X-RAY TO CHECK LEAD PLACEMENT TO DETERMINE THE CIRCUMSTANCES OF THE SWELLING AT THE IMPLANT SITE. NO STEPS WERE TAKEN TO RESOLVE THE SWELLING, OTHER THAN X-RAYS BEING TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134395 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 00056 YR