MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number NEU_INS_STIMULATOR

Device Problems Insufficient Information (3190); Data Problem (3196)

Patient Problems Emotional Changes (1831); Headache (1880); Muscular Rigidity (1968); Nausea (1970); Vomiting (2144); Dysphasia (2195); Depression (2361); Dyskinesia (2363); Diaphoresis (2452); Shaking/Tremors (2515); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a patient had a deep brain stimulation device and in (b)(6) 2022 they went to the accident and emergency hospital with an acute deterioration in their symptoms.They were experiencing severe headaches, vomiting and severe involuntary movements.Following a ct brain scan and additional blood tests the cause was found to be an error message on the patient programmer.The device had previously been implanted for parkinson's disease, however on this occasion the voltage settings had somehow reset, which was causing the symptoms.Once the programmer was used to reset the patient's settings the patient's symptoms resolved.The cause of the issue remains unclear.

Event Description

Straw, i., ashworth, c., radford, n.When brain devices go wrong: a patient with a malfunctioning deep brain stimulator (dbs) presents to the emergency department.Bmj case rep 2022;15:e252305.Doi:10.1136/bcr-2022-252305 summary a man in his 50s attended the emergency department with an acute deterioration in his parkinson¿s symptoms, presenting with limb rig idity, widespread tremor, choreiform dyskinesia, dysarthria, intense sadness and a severe occipital headache.After excluding common differentials for sudden-onset parkinsonism (eg, infection, medication change), an error on the patient¿s deep brain stimulator was noted.The patient¿s symptoms only resolved once he was transferred to the specialist centre so that the programmer could reset the device settings.Due to covid-19-related bed pressures on the ward, there was a delay in the patient receiving specialist attention¿highlighting the need for non-specialist training in the emergency management of device errors.Reported events: 1.A man in his 50's with an implantable deep brain stimulation (dbs) device for parkinson's presented at the emergency room (er) with an acute deterioration in his parkinson's symptoms.Their symptoms of rigidity and tremor were usually well controlled by the combination of levodopa and dbs.They reported that their medications were no longer effective, and his symptoms had intensified beyond his previous experience; he was exhibitingsevere dyskinesia with violent shaking of all four limbs at around three per second.He was sweaty, struggling to speak and the dyskinesia was associated with widespread rigidity and tremor.The patient was also reporting an intense occipital headache, associated with nausea, and he expressed intense sadness and emotional distress during his presentation.Examination of the patient¿s respiratory, cardiovascular and abdominal system did not demonstrate further pathology, however, the presence of the patient¿s neurostimulator in the patient¿s left pectoral region was noted.The patient¿s inflammatory and infective markers were within normal parameters and his additional bedside tests (covid-19 swab, urine dip and ecg) were normal.The only abnormality was the patient¿s creatine kinase, thought to be related to muscle breakdown relating to his extensive hyperkinesia.The ct brain scan did not demonstrate an acute event.On exploring the device user manual, they were able to interpret the error message on the device which indicated that he neurostimulator had desynchronized.With the assistance of the specialist team over the phone, attempts were made to reconfigure the device using the patient programmer in the department.Unfortunately, these attempts failed, and they were unable to resolve the patient¿s symptoms.For intermediary management, he was treated with intravenous fluids, analgesics and benzodiazepines which had a limited effect on improving his symptoms.Due to bed pressures related to covid-19, transferring the patient to the specialist hospital was delayed.Once this transfer was arranged and the programmer was available to attend to the patient, the correction of the dbs settings immediately resolved the patient symptoms.The patient remained in the specialist hospital for a few days following the resolution of his symptoms, during which time causes for the device error were explored.On examination, it appeared that the dbs settings had been unintentionally reset and once the correct voltage and frequency settings were reinstated the patient improved immediately.The cause of the change in the dbs settings remains unclear, these settings can only be adjusted using the clinician¿s programmer as opposed to the patient¿s programmer which they have at home.As a result, it should not be possible for the parameters to changeoutside of the clinical setting.Once discharged, the patient returned to his previous functional baseline, his symptoms being controlled with his regular medications and reconfigured dbs hardware.See attached literature article.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15349684
• MDR Text Key: 299183589
• Report Number: 2182207-2022-01687
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2023
• 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
• Patient Age: 50 YR
• Patient Sex: Male