BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3140303 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08476
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 13, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS (B)(4): A HEAT TEST WAS PERFORMED TO ADDRESS THE COMPLAINT OF OVER-HEATING WHILE RECHARGING; THE COMPLAINT WAS UNABLE TO DUPLICATED IN THE LAB, THERE WERE NO ANOMALIES FOUND. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (S/N (B)(4)) WAS FUNCTIONALLY OK AND FOUND NO SIGNIFICANT ANOMALY. ANALYSIS OF THE FIRST LEAD (S/N (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE SECOND LEAD (S/N (B)(4)) FOUND NO SIGNIFICANT ANOMALY, THE STIMULATION LEAD BODY CONDUCTOR WAS CUT ¿ OUTER INSULATION WAS BREACHED CUT AND THE #9 AND #13 ¿ CONDUCTORS WERE CUT 28.6CM FROM THE DISTAL END.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED, THE PATIENT¿S SYSTEM WAS COMPLETELY EXPLANTED. IT WAS NOTED THE PATIENT THOUGHT THEY MAY BE ALLERGIC TO TITANIUM BECAUSE THEY HAD SCREWS IN THEIR BACK THAT GAVE THEM PROBLEMS IN THE PAST. REPORTEDLY THE PATIENT NEEDED AN MRI AND THEY HAD NOT HAD GOOD THERAPY. THE PATIENT¿S OUTCOME WAS REPORTED AS NO INJURY OR ADVERSE EVENT AND IT WAS STATED THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HAD AN MRI AND EVER SINCE THE MRI THE POCKET SITE BURNED WHEN THEY RECHARGED THEIR DEVICE. IT WAS NOTED THE RECHARGER ITSELF DID NOT OVER HEAT. THE PATIENT HAD COVERAGE BUT IT WAS NOT HELPING THEIR PAIN.SYMPTOMS INCLUDED A BURNING SENSATION AND LESS THAN 50% THERAPY RELIEF. PATIENT STATUS WAS NOTED AS NO INJURY OR ADVERSE EVENT. PATIENT WAS SCHEDULED FOR EXPLANT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241799 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention