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

Model Number 37612

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Scar Tissue (2060); Dysphasia (2195); Discomfort (2330); Electric Shock (2554); Insufficient Information (4580)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

It was reported that the patient had gotten a shocking sensation while charging and when turning their device off or on for the last 3 years (see rtg0129991 for the report of shocking when charging).The patient said they felt the shocking sensation even when the device was turned off.They also noted that pressing on the right side of the implantable neurostimulator ins will shock them even though the device was turned off.There is no known reason or factor for this issue to be occurring.To resolve the shocking sensation, the patient was upgraded to the new wireless recharger wr (see mpxr 1020143 wr upgrade), and they said that it seemed to be less of a shock using the new system than the old wired system.The patient will have an appointment with the rep and the hcp on 10/13/2023 to troubleshoot and evaluate the issue.The patient had had the dbs off for the last 3 months but continued to feel the shocking sensation. the problem was not resolved by the time of this report.

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.

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

Additional information received from the manufacturer¿s representative (rep) reported the patient had their device off for the last three months because of the shocking issue.

Manufacturer Narrative

D10: product id 37751, serial# unknown.Product type: recharger.Product id wr9200, serial# unknown.Product type: recharger.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 from the patient that both the legacy recharger and wireless recharger (wr) are shocking her.Patient and physician don't know why they're getting shocked.This has been an issue since july 2020 and since using the wr since this past may, the patient gave conflicting information that they no longer feel shocks and also still feels shocks.Patient stated they can't use the wr with the drape as her neck is short or it sits to the right of the battery so patient uses adhesive discs.Patient states previously being shocked like a dystonia storm.Patient states they have reduced the voltage 4 times.Patient still feels shocking on right side of head, across left side and then to ins on both sides.Patient states it feels like they touched an electrical socket.Patient is scheduled for a mri on monday so they charged the ins.Ins showed low.Patient had a difficult time with the antenna but the wr fully charged ins.Patient states the ins has helped because they've gone a couple months without it being on.Patient states last night getting a por message on the programmer.Ins is fully charged.Patient used programmer navigator button and it showed a clock.Patient states when changing the clock she shut the ins off.Patient turned ins on and states it is shocking her bad.Patient turned ins back off.Patient states it was affecting her voice box.

Event Description

The rep informed that stimulation has been off for 3 months and patient is still feeling shocking at the ins pocket with certain movements.

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.

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

Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the patient was seen in clinic to evaluate the issues they had been having.X-rays were taken and the system looked intact and no wires were found crossing on top of the battery.Impedance measurements were also taken numerous times while palpating the battery and having the patient move their arm and neck and all checks came back within normal limits.The clinician felt like some of the sensitivity that the patient may be experiencing when pushing on the device could be a nerve or scar tissue that is inflamed from the different battery changes that have occurred over the years.The clinician also feels like some of the sensation that the patient feels at times when charging and palpating the device may be psychogenic.This was tested by asking the patient if they could feel any of the stimulation as we pretended to run an impedance check.Each time we pretended, the patient said they could feel tingling all up and down their arms and legs.However, if we ran impedance measurements without letting her know that we were actually running them, the patient did not seem to feel or even know the check was being done.At this time the clinician recommend the patient leave the dbs off because her symptoms still have not come back despite the patient having it off for 3 months.The patient will continue to charge the system periodically so that impedances can be taken in the event that she would ever need an mri.The patient was also instructed to stop pushing on the sore spots to help prevent her from feeling any pain (the patient did not use a charging sling as it landed on the sore spot).The patient did say that she saw a por message on her programmer a few days ago but there is no known reason as to why.Impedances shows normal and we checked her system using her patient programmer and did not see any por messages.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 17909891
• MDR Text Key: 326252155
• Report Number: 3004209178-2023-17380
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2023
• Date Device Manufactured: 07/12/2018
• 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...."
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 77 KG