MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

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

Patient Problems Complaint, Ill-Defined (2331); Cognitive Changes (2551)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Testo aa, garnaat sl, corse ak, et al.A case of non-affective psychosis followed by extended response to non-stimulation in deep brain stimulation for obsessive-compulsive disorder.Brain stimul.2020;13(5):1317-1319.10.1016/j.Brs.2020.06.019.The study sought to investigate effectiveness of dbs as a treatment for intractable ocd, as preliminary data had shown promising therapeutic effects.Reported events: approximately 18 months after implantation, the patient presented with an acute onset of psychotic symptoms shortly after dbs amplitude was increased.At the following visit dbs voltage was reduced, but psychotic symptoms persisted.The patient described ideas of reference, magical thinking unrelated to any previous ocd symptoms (e.G., talking to trees), and other delusional beliefs.There was no accompanying grandiosity, euphoria, pleasure-seeking, or change in sleep suggesting hypomania.His functioning worsened in tandem.An antipsychotic was started (risperidone 2mg/day).The patient's condition improved with stimulation turned off and an increased dose in medication.The patient's stimulation was turned off for 2 years, and ocd symptoms remains in control.After two years the patient's ocd symptoms retuned so stimulation was turned back and the patient's condition improved.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10531955
• MDR Text Key: 206968373
• Report Number: 2182207-2020-00876
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2020
• 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): Other
• Patient Age: 20 YR