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

Model Number 37612

Device Problems High impedance (1291); Impedance Problem (2950)

Patient Problems Visual Disturbances (2140); Dysphasia (2195); Numbness (2415)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_lead lot# unknown, product type lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.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 the patient was showing high impedance values for monopolar impedances where as bipolar impedances seemed normal.The patient currently was experiencing sufficient therapy.Additional information was received: it was reported that the patient was in a sitting position during both measurements.The patient also developed some symptoms that came and went, such as numbness in the fingertips and numbness in the eye and cheek, all on the right side.When impedances were measured, they saw stars.They had previously described it as flashing before his eyes.  monopolar impedances were high on contact 0 and bipolar impedances on contact 0 were also high.At first these were shown as normal.The impedance behavior was intermittent.Additional information was received: it was reported that the cause was not determined yet.The hcp was trying to reprogram and follow up the patient.The impedance deviation had not been solved but they were waiting to see if reprogramming helped the patient.

Event Description

Additional information was received: it was reported that the patient was called in this time because they suddenly had problems with numbness in their right cheek and eye with numbness in their right hand.They also had a brief speech impact as their family barely heard what they were saying.At the first measurement when the patient arrived, the impedances on the left electrode were high in both monopoly mode and in bipolar mode when measuring 0.7v, 1.5v and 3.0v.They were able to trace the problem to pole 0 and chose to disable it.In impedance measurement the next time after deactivating pole 0, the impedance was unremarkable at 0.7v.When measured with 1.5v, the impedances were high in both monopoly and bipolar mode, just as before.When measured with 3.0v, the impedances were without remark again.The patient received small flashes/stars in front of the eyes during all impedance measurements.On the right electrode, the impedances are unremarkable in monopolar but not in bipolar mode when measuring with 0.7v.When measuring at 1.5v and 3.0v, the impedances are without remark.After deactivating pole 0, all the patient's unpleasant symptoms disappeared.The patient has activa an rc and was programmed with cv.The patient was there at the clinic for a whole day and several impedance measurements were made during the day.The patient was seated during all measurements and the results of impedance measurements varied.The patient did not have full therapy effect when pole 0 was active.They thought the dystonia in their neck was a little worse than before.After we deactivated pole 0, the therapy effect has been good.The patient stated the symptoms they had when pol 0 was active are completely gone.

Manufacturer Narrative

Continuation of d10: product id neu_unknown_lead lot# unknown 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: 16673933
• MDR Text Key: 312864864
• Report Number: 3004209178-2023-04480
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2023
• Date Device Manufactured: 06/11/2020
• 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
• Treatment: "SEE H10...."