MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

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

Patient Problems Emotional Changes (1831); Distress (2329); Depression (2361); Irritability (2421); Shaking/Tremors (2515); Cognitive Changes (2551)

Event Date 08/01/2013

Event Type  Injury  

Manufacturer Narrative

Citation: gilbert, f., viaña, j.N.M.A personal narrative on living and dealing with psychiatric symptoms after dbs surgery.Narrative inquiry in bioethics.2018; 8(1): 67-77.B3: month and year valid, per article.Implant date was (b)(6) 2013.Event occurred in (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: although deep brain stimulation (dbs) may result in dramatic motor improvement in people with parkinson¿s disease (pd), it has been correlated with a number of postoperative psychiatric side effects.The authors report a case of a person with pd experiencing depression and hypomania following dbs surgery, and present a detailed report of the patient¿s personal experiences dealing with and managing these psychiatric side effects for three years.Providing a personal narrative focusing on detailed patient subjective experiences complements reports that give insight into the short- and long-term effects of dbs on established psychiatric measures and neurologic activity.But, most importantly, such a qualitative approach provides prospective patients and clinicians with a broader ethical picture of real-life challenges faced and coping strategies employed by pd patients treated with dbs who are experiencing psychiatric adverse events.This case study reinforces the ethical need to disclose the potential risk of harm to prospective patients as well as the importance of establishing a multidisciplinary postoperative supportive group reported event: a (b)(6) female patient implanted with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) experienced substantial parkinsonian tremor post-surgery, which required adjustment of stimulation parameters.Calibration of parameters resulted in significant diminution of motor symptoms; however, concomitant psychiatric symptoms emerged including depression, mania/hypomania, hypersexuality, intense distress, sever postoperative impulsivity, and self-estrangement.The patient had no history of mental health issues.Zoloft and seroquel were prescribed for depression and mania.In the months following the procedure, the patient experienced a wide range of feelings, especially intense distress.The therapeutic relationship with her neurologist and surgical team broke down, the patient went through a divorce and moved to another state, and ultimately attempted suicide in (b)(6) 2014.The patient's suicide attempt was thought to have been precipitated by the persistent feelings of distress and the breaking down of relationships.A feeling of lack of power/loss of control, notably when the patient was angry, accompanied the patient's impulsivity.The impulsivity also presented as radically enhanced capacities in the form of increased uncontrollable sexual urges and greater physical energy.The patient experienced involuntary and unintentional shift in character/behavior including copulating in the hospital bathroom, walking 5 kilometers to and from a doctor's appointment, and buying a backless dress shortly after brain surgery.The patient reported a persistent state of self-perceived changes, perception of strangeness, and alteration in concept of self more than one year after implant.The patient stated, "[i] can't be the real me anymore¿ the person that i have been [since the intervention] was somehow observing somebody else, but it wasn't me¿ i am who i am now.But it's not the me that went into the surgery." the patient's family reportedly "grieved" for the old patient, and no longer recognized the patient who seemed to "change [her] mind all the time".A psychiatrist suggested turning the settings down to manage the patient's emotional state, as they believed she was bordering on mania; however, the patient felt it was not over the top and was "just joy." the patient eventually began to indicate progressive copying with the postoperative changes, and described the "old version" (pre dbs) wouldn't have been able to cope or "stand on her own two feet." the patient began expressing emotion through colored painting, and began selling some of her creations.The patient described herself as a "totally different person" with a greater appreciation for art, photography, music, and color.It was noted she still faced challenges linked to this new self, but had developed an attitude to embrace several aspects of it.See attached literature article.No device specifics were identified.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7626124
• MDR Text Key: 111916928
• Report Number: 3007566237-2018-01853
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2018
• 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): Life Threatening
• Patient Age: 46 YR