BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3131687 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08244
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 8, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3550-39, LOT# N362814, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS (B)(4) FOUND NO ANOMALY. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE SURGERYWAS SCHEDULED FOR JUNE 21, 2013. FURTHER FOLLOW UP REPORTED THE REPLACEMENT TOOK PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TELEMETRY ISSUES WITH THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) AND AN OVERDISCHARGE CONDITION SUSPECTED. IT WAS NOTED THAT THE OVERDISCHARGE WAS DUE TO ¿PATIENT EDUCATION ISSUES¿. THE PATIENT INDICATED THAT IT WAS A BRAND NEW DEVICE AND DID NOT NEED TO CHARGE. IT WAS REPORTED THAT THE PATIENT HAD NEVER CHARGED THE DEVICE. THE LAST TIME ANY STIMULATION WAS FELT WAS 2 MONTHS AGO. THE PATIENT MET WITH THE MANUFACTURER¿S REPRESENTATIVE ON (B)(6) 2013 AT WHICH TIME 3 PHYSICIAN MODE RECHARGE (PMR) PROCEDURES WERE PERFORMED BUT DID NOT LEAD TO A NORMAL CHARGING SCREEN. IT WAS ALSO REPORTED THAT THE PATIENT PERFORMED 1 PMR PROCEDURE AT HOME. THE ANTENNA LOCATOR (AL) FEATURE AND A COUPLING OF 60 WAS NOTED. THE PATIENT AGAIN MET WITH THE MANUFACTURER¿S REPRESENTATIVE ON (B)(6) 2013 AT WHICH TIME ANOTHER PMR WAS PERFORMED (AL FEATURE SHOWED A COUPLING OF 60) BUT COULD NOT GET A NORMAL CHARGE SCREEN. IT WAS NOTED THAT THE INS POCKET DID NOT APPEAR TO BE LOOSE. FOLLOW UP INFORMATION CONFIRMED THAT THE PMR PROCEDURE ATTEMPTS WERE UNSUCCESSFUL AFTER 3 ATTEMPTS. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY STIMULATION DURING THE EVENT. THE PATIENT WAS SCHEDULE TO SEE THEIR PHYSICIAN ON (B)(6) 2013 FOR AN X-RAY. FURTHER FOLLOW UP INFORMATION REPORTED THAT X-RAY SHOWED THAT THE INS BATTERY WAS IN THE PROPER ANATOMICAL POSITION. A TOTAL OF 6 (¿OR MORE¿) PMR PROCEDURES WERE PERFORMED BUT THE BATTERY REMAINED IN A DISCHARGED CONDITION. THE PLAN WAS TO REPLACE THE INS BATTERY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS WAITING FOR A SURGERY DATE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS DOING VERY WELL, WITH NO PROBLEMS. A NON-RECHARGEABLE SYSTEM WAS IMPLANTED. THE COMPANY REPRESENTATIVE STATED HE FELT THIS WAS AN ISSUE OF PATIENT NONCOMPLIANCE. IT WAS ALSO STATED THAT THE DEVICE HAD BEEN MAILED BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234277 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 00063 YR Required Intervention