BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5072187 · Received September 11, 2015

    Report

    Report Number
    3007566237-2015-02577
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    June 25, 2015
    Report Date
    August 18, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_STIMLOC_ACC, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    FALOWSKI, S.M., OOI, Y.C., BAKAY, R.A. LONG-TERM EVALUATION OF CHANGES IN OPERATIVE TECHNIQUE AND HARDWARE-RELATED COMPLICATIONS WITH DEEP BRAIN STIMULATION. NEUROMODULATION: JOURNAL OF THE INTERNATIONAL NEUROMODULATION SOCIETY. 2015: DOI: 10.1111/NER.12335 SUMMARY: DEEP BRAIN STIMULATION IS THE MOST FREQUENT NEUROSURGICAL PROCEDURE FOR MOVEMENT DISORDERS. WHILE THIS ELECTIVE PROCEDURE CARRIES A LOW-RISK PROFILE, IT IS NOT FREE OF COMPLICATIONS. AS A NEW PROCEDURE, THE PATTERN OF COMPLICATIONS CHANGED WITH EXPERIENCE AND MODIFICATION OF SURGICAL TECHNIQUE AND EQUIPMENT. THIS REVIEW ANALYZES THE MOST COMMON HARDWARE-RELATED COMPLICATIONS THAT MAY OCCUR AND TECHNIQUES TO AVOID THEM. IT IS A RETROSPECTIVE REVIEW OF 432 PATIENTS UNDERGOING 1077 PROCEDURES OVER A 14-YEAR PERIOD BY ONE SURGEON WITH EMPHASIS ON THE ANALYSIS OF SURGICAL TECHNIQUE AND THE CHANGES OVER TIME. COMPARISONS WERE MADE PRE AND POSTIMPLEMENTATION OF DIFFERENT SURGICAL TECHNIQUES OVER DIFFERENT TIME PERIODS. THE EPOCHS RELATE TO THE LEARNING CURVE, NEW EQUIPMENT, AND NEW TECHNIQUES. OVERALL LEAD REVISION WAS OBSERVED AT 5.7%, EXTENSION REVISION AT 3.2%, INFECTION RATE AT 1.2%, INFARCT WITHOUT INTRACEREBRAL HEMORRHAGE AT 0.8%, AND INTRACEREBRAL HEMORRHAGE AT 2.5% WITH A PERMANENT DEFICIT OF 0.2%. AN ANALYSIS AND CHANGE IN SURGICAL TECHNIQUE WHICH INVOLVED ISOLATING THE LEAD FROM THE SKIN SURFACE AT BOTH THE CRANIAL AND RETRO-AURICULAR INCISION ALSO DEMONSTRATED A SUBSTANTIAL DECREASE IN LEAD FRACTURE RATE AND INFECTION RATE. THERE WAS NO MORTALITY. THIS LARGE SERIES OF PATIENTS AND LONG-TERM FOLLOW-UP DEMONSTRATES THAT RISKS ARE VERY LOW IN COMPARISON WITH OTHER NEUROSURGICAL PROCEDURES, BUT DBS IS STILL AN ELECTIVE PROCEDURE THAT NECESSITATES EXTENSIVE CARE AND PRECISION. IN A RAPIDLY EVOLVING FIELD, ATTENTION TO SURGICAL TECHNIQUE IS IMPERATIVE AND WILL KEEP RATES OF COMPLICATIONS AT A MINIMUM. REPORTED EVENTS: 1. 6 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) IMPLANTED BETWEEN 1996 AND 2000 EXPERIENCED DISTAL LEAD FRACTURES IN THE NECK. 2. 1 PATIENT WITH DBS IMPLANTED BETWEEN 1996 AND 2000 EXPERIENCED FRACTURE REQUIRING A REVISION OF THE EXTENSION LEAD. 3. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED A DISTAL LEAD CRACK AT THE EXTENSION LEAD AND REQUIRED A REVISION. 4. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED A DISTAL LEAD CRACK AT THE STIMLOC CAP AND REQUIRED A REVISION. 5. 3 PATIENTS WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED HIGH IMPEDANCES AND REQUIRED A REVISION OF THE LEAD. 6. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED LEAD MIGRATION AND A LOSS OF EFFICACY. THE PATIENT REQUIRED A REVISION. 7. 17 PATIENTS WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED A LOSS OF EFFICACY AND REQUIRED A REVISION OF THE LEAD. IT WAS NOTED THAT THE MAJORITY OF REVISIONS FOR LACK OF EFFICACY OCCURRED AFTER SEVERAL YEARS OF ADEQUATE RELIEF WITH STIMULATION AND NOT SECONDARY TO LEAD MIGRATION. LACK OF EFFICACY IN THESE CASES WAS DUE TO THE INABILITY TO DELIVER THERAPEUTIC STIMULATION WITHOUT ADVERSE EFFECTS. 8. 4 PATIENTS WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED NEW ADVERSE EFFECTS AND REQUIRED A REVISION OF THE LEAD. 9. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN EXTENSION LEAD BREAK. IT WAS NOTED THAT THE EXTENSION FRACTURED FOLLOWING A FALL. THE PATIENT REQUIRED A REVISION. 10. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN EXTENSION LEAD BREAK/FRACTURE. THE PATIENT REQUIRED A REVISION. 11. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED A BILATERAL FRACTURE OF THE EXTENSION LEADS. THE PATIENT REQUIRED A REVISION. 12. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN EXTENSION LEAD FRACTURE IN THE CHEST. THE PATIENT REQUIRED A REVISION. 13. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN EXTENSION FRACTURE AFTER A FALL. THE PATIENT REQUIRED A REVISION. 14. 2 PATIENTS WITH DBS IMPLANTED BETWEEN 2001 AND 2010 REQUIRED AN EXTENSION LEAD REVISION. IT WAS NOTED THAT THE EXTENSION HAD COILED ON ITSELF AT THE CONNECTOR AND HAD HIGH IMPEDANCES. 15. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 REQUIRED AN EXTENSION LEAD REVISION DUE TO THE LEAD EXTENSION DISCONNECTING. 16. 2 PATIENTS WITH DBS IMPLANTED BETWEEN 2001 AND 2010 REQUIRED AN EXTENSION LEAD REVISION DUE TO HIGH IMPEDANCES IN THE SYSTEM. 17. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 REQUIRED AN EXTENSION LEAD REVISION DUE TO A SYSTEM MALFUNCTION AFTER MULTIPLE FALLS. IT WAS NOTED THAT THERE WAS NO FRACTURE. 18. 2 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) IMPLANTED BETWEEN 1996 AND 2000 EXPERIENCED AN INFECTION OF THE SCALP INCISION. 19. 1 PATIENT WITH DBS IMPLANTED BETWEEN 1996 AND 2000 EXPERIENCED AN INFECTION OF THE SCALP INCISION AND REQUIRED REMOVAL, BUT "LEFT LEAD." 20. 1 PATIENT WITH DBS IMPLANTED BETWEEN 1996 AND 2000 EXPERIENCED AN INFECTION OF THE SCALP AND RETROAURICULAR INCISIONS. 21. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN INFECTION OF THE RETROAURICULAR INCISION. IT WAS NOTED THAT THERE WAS NO HARDWARE CHANGE DONE. 22. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN INFECTION OF THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE INS AND EXTENSION LEAD WERE REMOVED. 23. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN INFECTION AND CONNECTOR SITE EROSION AFTER A FALL. THE PATIENT UNDERWENT A REVISION AND THEN RETURNED FOR A SECOND REVISION AND REMOVAL OF THE EXTENSION AND IMPLANTABLE NEUROSTIMULATOR (INS) AFTER FAILED ANTIBIOTICS. 24. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN INFECTION AND CONNECTOR SITE EROSION. THE EXTENSION WAS REMOVED. 25. 4 PATIENTS WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN INFECTION AT THE RETROAURICULAR INCISION. THE EXTENSION LEAD AND INS WERE CHANGED, BUT A SECOND REVISION WAS DONE WITH REMOVAL OF HARDWARE. 26. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN INFECTION AT THE RETROAURICULAR INCISION. BOTH THE EXTENSION LEAD AND INS WERE REMOVED. 27. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN INFECTION OF THE RIGHT INS AND SCALP. THE PATIENT UNDERWENT TWO REVISIONS AND TWO COURSES OF ANTIBIOTICS. IT WAS NOTED THAT THERE WAS NO HARDWARE REMOVAL. 28. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED AN INFECTION OF THE RETROAURICULAR INCISION AND SCALP INCISION. THE PATIENT UNDERWENT A REVISION AND RETURNED FOR A SECOND REVISION/REMOVAL OF THE DBS EXTENSION LEAD AFTER FAILED ANTIBIOTICS. IT WAS NOTED THAT ONLY THE EXTENSION LEAD WAS REMOVED. 29. AN UNKNOWN NUMBER OF PATIENTS HAD A CULTURE POSITIVE FOR STAPHYLOCOCCUS AUREUS. 30. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED SKIN EROSION AT THE CONNECTOR AND REQUIRED A WOUND REVISION. IT WAS NOTED THAT THERE WAS NO INFECTION AS THE CULTURE WAS NEGATIVE. 31. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED SKIN EROSION JUST DISTAL TO THE CONNECTOR AND REQUIRED A WOUND REVISION. IT WAS NOTED THAT THERE WAS NO INFECTION AS THE CULTURE WAS NEGATIVE. 32. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED SKIN EROSION AT THE STIMLOC. THE STIMLOC WAS CHANGE. IT WAS NOTED THAT THERE WAS NO INFECTION AS THE CULTURE WAS NEGATIVE. 33. 7 PATIENTS WITH DBS IMPLANTED BETWEEN 1996 AND 2000 EXPERIENCED INTRACEREBRAL HEMORRHAGE (ICH) AS DETERMINED BY RADIOLOGY REPORTS ON POSTOPERATIVE MRI. 34. 1 PATIENT WITH DBS IMPLANTED BETWEEN 1996 AND 2000 EXPERIENCED INTRACEREBRAL HEMORRHAGE (ICH) AS DETERMINED BY RADIOLOGY REPORTS ON POSTOPERATIVE MRI WITH PERMANENT POSTOPERATIVE WEAKNESS. 35. 2 PATIENTS WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED ICH AND INTRAVENTRICULAR HEMORRHAGE (IVH) AS DETERMINED BY RADIOLOGY REPORTS ON POSTOPERATIVE MRI. 36. 1 PATIENT WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED ICH, IVH, AND SUBDURAL HEMATOMA (SDH) AS DETERMINED BY RADIOLOGY REPORTS ON POSTOPERATIVE MRI. THE PATIENT REQUIRED A SHUNT AND HAD PERMANENT POSTOPERATIVE WEAKNESS. 37. 6 PATIENTS WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED ICH. 38. 2 PATIENTS WITH DBS IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED ICH AS DETERMINED BY RADIOLOGY REPORTS ON POSTOPERATIVE MRI WITH CONFUSION AND AGITATION. THE PATIENTS WERE DISCHARGED TO A SKILLED NURSING FACILITY. 39. 1 PATIENT WITH DBS EXPERIENCED A THALAMIC CEREBROVASCULAR ACCIDENT (CVA) AS CONFIRMED BY POSTOPERATIVE MRI WITH TRANSIENT WEAKNESS. 40. 3 PATIENTS WITH DBS EXPERIENCED ASYMPTOMATIC THALAMIC CEREBROVASCULAR ACCIDENTS (CVA) AS CONFIRMED BY POSTOPERATIVE MRI. 41. 1 PATIENT WITH DBS (SANTE STUDY REVISION) IMPLANTED BETWEEN 2001 AND 2010 EXPERIENCED ICH AS DETERMINED BY RADIOLOGY REPORTS ON POSTOPERATIVE MRI. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604056 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention