MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Neurological Deficit/Dysfunction (1982); Electric Shock (2554); Unspecified Nervous System Problem (4426)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown.Product id: neu_unknown_ext, serial/lot #: unknown.Product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturing representative about a patient with an implantable neurostimulator (ins) for dystonia.It was reported that the patient received a new ins, and since then they have been feeling electrical sensations in both legs.No further complications were reported or anticipated.Additional information was received from a health care provider (hcp).It was reported that the cause of the issue was not determined.There was no problem seen with the ins.The patient will be reprogrammed and they will follow the issue over time.No further action is planned.Additional information was received from a hcp.It was reported that the patient was having a severe problem with their dystonia in their upper thoracic region, neck and mouth.This issue has just worsened and worsened over a short period of time.The patient has gone from very good benefit to very poor.Asa result of the symptoms, the patient underwent a bilateral extension replacement.No electrical sensations can be provoked by palpating the system.It was stated that the hcp believes it is something with the patient's left lead.Device interrogation results were reviewed and impedance values were tested, however no anomaly with the patient's system were seen.Options for reprogramming the patient's settings were discussed.

Manufacturer Narrative

Product id: 3708640, serial# unknown, implanted: (b)(6) 2019, product type: extension; product id: 3708640, serial# unknown, implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: extension; product id: 3389, lot# unknown, product type: lead; product implant and explant dates are year valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received indicating the customer was following the electrode and therapy impedances and nothing was found, no changes at all.No further cause was determined.The adjustment of the amplitude to a lower amplitude where the patient felt the stimulation comfortably was taken to attempt to resolve the issue.The issue remained unresolved.

Manufacturer Narrative

D2: please note that this device was used in an off-label manner as it was implanted for dystonia.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

Additional information was received: it was reported that the patient still wasn't experiencing optimal stimulation on their left side for dystonia.Impedances were all in normal range.Data reports were checked and no irregularities were noticed that would cause less optimal stimulation.It was also confirmed that from implant date of (b)(6) 2018 to (b)(6) 2022 that stimulation was on 100% of the time other than 2 hours (which could be related to certain medical procedures taking place).There was an issue with group usage of (b)(6) 2020 displayed, but could be explained by a known bug with the older software versions.Additional information was received indicating that there was a scan for the leads and the leads were in place like from the beginning.The patient went home with a new settings group, but didn't get 100% therapy results.

Manufacturer Narrative

Continuation of d10: product id 3708640 lot# serial# unknown implanted: (b)(6) 2019 explanted: product type extension product id 3708640 lot# serial# unknown implanted: (b)(6) 2018 explanted: (b)(6) 2019 product type extension product id 3389 lot# unknown serial# implanted: explanted: product type lead 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: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 9151458
• MDR Text Key: 163719654
• Report Number: 3004209178-2019-18915
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2022
• Date Device Manufactured: 08/27/2018
• 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
• Treatment: "SEE H10...."; "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Female