MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Neurological Deficit/Dysfunction (1982); Pain (1994); Skin Erosion (2075); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Distress (2329); Complaint, Ill-Defined (2331); Cognitive Changes (2551); No Code Available (3191)

Event Type  Death  

Manufacturer Narrative

Additional review of this event determined that the patient's death was related to the progression of the patient's underlying terminal illness and was not related to the dbs device or therapy.The dbs was implanted as a management of the patient's pain caused by the dystonia and was not effective in improving symptoms.(b)(4).

Event Description

Strand jj, feely ma, kramer nm, moeschler sm, swetz km.Palliative sedation and what constitutes active dying: a case of severe progressive dystonia and intractable pain.The american journal of hospice <(>&<)> palliative care.2014:pii 1049909114561997 summary: we present the case of a (b)(6) woman with klippel-feil syndrome who developed progressive generalized dystonia of unclear etiology, resulting in intractable pain despite aggressive medical and surgical interventions.Ultimately, palliative sedation was required to relieve suffering.Herein, we describe ethical considerations including defining sedation, determining prognosis in the setting of an undefined neurodegenerative condition, and use of treatments that concurrently might prolong or alter end-of-life trajectory.We highlight pertinent literature and how it may be applied in challenging and unique clinical situations.Finally, we discuss the need for expert multidisciplinary involvement when implementing palliative sedation and illustrate that procedures and rules need to be interpreted to deliver optimal patient-centered plan of care.Event: one (b)(6) female patient underwent implantation of bilateral deep brain stimulation (dbs) as a restorative and palliative therapy aimed at improving the patient¿s pain and dystonia related to the patient¿s diagnosis of klippel-feil syndrome (syndrome resulting in fusion of the fifth and sixth cervical vertebraeand associated syringomyelia).Although some initial improvement in her dystonia was observed, the patient quickly decompensated-developing dysautonomia, increasing dystonia, resulting in severe pain.No specific etiology for the patient¿s clinical decompensation was revealed during evaluation.In this setting, both palliative care and interventional pain services were consulted to assist with pain and symptom management.Despite the use of high-dose intravenous opioid infusions (morphine and then hydromorphine) as well as adjunctive benzodiazepines, the patient¿s pain continued unabated.Given possible concern about opioid-associated hyperalgesia, the patient¿s opioids were rotated to intravenous methadone.The patient was initiated on parenteral dexmedetomidine, given previous reports of its use in the treatment of severe pain crises and opioid-associated hyperalgesia.With these changes, the patient initially experienced a significant improvement in her pain.During the brief respite, the patient engaged in more nuanced discussions about the goals of her care and made it clear that she did not wish to suffer and wished to maximize pain control above all other aspects of her care.After multiple attempts to both control the patient¿s pain while maximizing alertness led to worsening of the patient¿s severe pain and unbearable suffering, palliative sedation was discussed.Palliative sedation was begun by increasing the dose of dexmedetomidine and by initiating a basal infusion of midazolam with nursing-administered boluses of midazolam for breakthrough symptoms, including agitation.Opioid analgesics were continued as they were previously utilized.Despite these aggressive measures, the patient continued to experienced periods of alertness that were marked by both verbal and nonverbal markers of distress and pain.Despite attempts to achieve relief of suffering while targeting lighter levels of sedation, it was the judgment of all staff involved that deeper levels of sedation with reduction in the patient¿s level of consciousness were required to adequately relieve her suffering.With this, the medical team initiated infusion of parenteral propofol with excellent results (i.E., outward appearance of relief of suffering).The reporter stated that a unifying diagnosis of the patient¿s condition remained elusive; although it was agreed that the patient was suffering from a progressive, apparently irreversible, neurodegenerative condition, and that disease-modifying treatments were not available, there was lack of concrete clinical experienced to draw from to define a clear terminal phase.It was noted that attempts at ¿aggressive care,¿ including the recent placement of a dbs device, had not improved the patient¿s condition and such therapeutic efforts were potentially leading to a prolongation of the patient¿s suffering.Furthermore, although the clinical course of the patient¿s end-stage dystonia was unclear, the patient had several commonly encountered markers of end of life (delirium, cachexia, severe skin breakdown and an inability to perform any self-cares).Six days after initiation of palliative sedation, the patient died peacefully.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.

Manufacturer Narrative

Please note that the actual date of death was not provided in the article.This date is based on the date of publication of the article.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 aboutadditional information regarding the reported event.Concomitant: product id neu_unknown_lead, lot# unknown, product type lead.(b)(4).

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4424341
• MDR Text Key: 13968333
• Report Number: 3007566237-2015-00143
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 01/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 00034 YR