MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Intermittent Continuity (1121); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Loss of Data (2903); Device Operates Differently Than Expected (2913)

Patient Problems Head Injury (1879); Unspecified Infection (1930); Inflammation (1932); Irritation (1941); Paresis (1998); Staphylococcus Aureus (2058); Skin Erosion (2075); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Cognitive Changes (2551); Weight Changes (2607)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

A 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 products: product id neu_unknown_ext, lot # unknown, product type extension; product id neu_ ins_stimulator, lot # unknown, product type implantable neurostimulator.

Event Description

Luyten, l., hendrickx, s., raymaekers, s., gabriels, l., nuttin, b.Electrical stimulation in the bed nucleus of the stria terminalis alleviates severe obsessive-compulsive disorder.Molecular psychiatry.2015.1-9.Doi: 10.1038/mp.2015.124 summary: in 1998, we proposed deep brain stimulation as a last-resort treatment option for patients suffering from severe, treatment-resistant obsessive-compulsive disorder (ocd).Here, 24 ocd patients were included in a long-term follow-up study to evaluate the effects of electrical stimulation in the anterior limbs of the internal capsule (alic) and bed nucleus of the stria terminalis (bst).We find that electrical stimulation in the alic/bst area is safe and significantly decreases obsessions, compulsions, and associated anxiety and depressive symptoms, and improves global functioning in a blinded crossover trial (n = 17), after 4 years (n = 18), and at last followup (up to 171 months, n = 24).Moreover, our data indicate that bst may be a better stimulation target compared with alic to alleviate ocd symptoms.We conclude that electrical stimulation in bst is a promising therapeutic option for otherwise treatment resistant ocd patients.Reported events: 1 patient had a malfunctioning stimulator which was replaced.It was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.Two patients experienced a broken lead, which was replaced.It was noted that none of the reported adverse events were life threatening or resulted in any permanent.Three patients had faulty extensions (5 defects in total) which were revised.It was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.One patient had their implantable neurostimulator (ins) repositioned as a result of irritation and skin atrophy, due to weight loss.It was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.One patient experienced a skin infection of coagulase negative staphylococcus aureus which was treated with antibiotics.This was classified as a surgery related, but not device related adverse event.It was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.Twelve patients reported suicidal thoughts.This was classified as probably not stimulation-induced.It was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.Two unknown patients reported adverse or undesirable observations (e.G.Negative or deteriorated symptoms) relating to ¿suicidal thoughts¿ during the stimulation on phase of the blinded crossover trial.Reported observations that were clustered into this category included, ¿more suicidal thoughts.¿ it was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.Two patient¿s stimulators were turned off on repeated occasions.It was noted the reason for these unwanted changes in stimulation parameters was unknown, but the patients were reminded to avoid strong electric or magnetic fields (e.G.Large stereo speakers with magnets, airport/security screening devices).It was noted that none of the reported adverse events were life threatening or resulted in any permanent.One patient¿s stimulator was turned off and reset to factory settings.It was noted the reason for this unwanted change in stimulation parameters was unknown, but the patient was reminded to avoid strong electric or magnetic fields (e.G.Large stereo speakers with magnets, airport/security screening devices).It was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.Three unknown patients reported adverse or undesirable observations (e.G.Negative or deteriorated symptoms) relating to ¿physical inconveniences related to implant¿ during the stimulation on phase of the blinded crossover trial.Reported observations that were clustered into this category included, ¿sensation of the cables; sensation of the stimulator in abdomen; shifting of the stimulator.¿ it was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.One unknown patient reported hallucinations during the stimulation on phase of the blinded crossover trial.It was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.Eleven unknown patients experienced a total of 23 hospitalizations which were ¿illness-related and in some instances worsened by difficult family circumstances.¿ it was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.One patient experienced local transient inflammation of a suture after implantable neurostimulator (ins) replacement.This was classified as a surgery related - infection, but not device related adverse event.It was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.One patient reported slow gastric emptying.This was classified as a stimulation-induced adverse event.It was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.One patient reported ¿blackout.¿ this was classified as probably not stimulation-induced.It was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.One patient experienced a minor head injury.This was classified as probably not stimulation-induced.It was noted that none of the reported adverse events were life threatening or resulted in any permanent impairment.The source literature included the following device specifics: lead models 3887, 3387, and 3391 and implantable neurostimulators itrel 2, synergy, or kinetra further information has been requested; a supplemental report will be submitted if additional information is received.

Event Description

Raymaekers, s., vanstreelandt, k., luyten, l., bervoets, c., demyttenaere, k., gabriels, l., nuttin, b.Long-term electrical stimulation of bed nucleus of stria terminalis for obsessive-compulsive disorder.Molecular psychiatry.2016.1-4.Doi: 10.1038/mp.2016.124.Additional information received from the authors reported that the patient's yale-brown obsessive-compulsive scale (y-bocs) showed a strong increase when stimulation was off, such as with empty batteries.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5158025
• MDR Text Key: 28563513
• Report Number: 3007566237-2015-03005
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 09/07/2016
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00039 YR