MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems High impedance (1291); Low impedance (2285); Impedance Problem (2950)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 07/23/2019

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: 64002, serial/lot #: (b)(4), ubd: 26-mar-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia.High impedances were measured on c/0 - 3664 ohms, c/1 - 3008 ohms and c/4 - 2724 ohms prior to ins replacement; the ins was at elective replacement indicator (eri).The ins and adaptor were replaced during the procedure.Immediately after replacement, there was high impedance on c/2 - 2418 ohms, but the previously mentioned contacts were in normal range between 800 and 1600 ohms.A measurement later in the day noted that impedance was still high at 2117 ohms on c/2, and bipolar pair 4/7 was low.A couple hours later, pair c/2 had normalized, but pairs 0/1, 4/7, 5/7, and 4/5 were low.The following day, the previously mentioned low impedance pairs had normalized in the range of 800 to 1600 ohms, but pair 1/2 was low.It was noted that no bipolar pair was used in programming.Therapeutic impedance decreased from 1117 and 739 ohms (left and right, respectively) to 484 and 557 ohms over the course of the day of replacement and increased to 597 ohms on the left and decreased to 512 ohms on the right the next day.It was noted that ins settings were different at each time that therapy impedance was measured.It was also noted that the medical team was considering explanting the device.The patient was reported to be unstable, although no specific symptoms were reported.Additional information was received from the hcp.It was stated that the patient's indication for use in dystonia.Device information was received.It was reported that the patient experienced a return of symptoms, and they were unstable.As a result of the symptoms and impedance issue, the adapter and extensions were explanted and replaced.At this time the extension replacement did not resolve the impedance issue, but there is good improvement in the patients dystonic state.Refer to manufacturer report #9614453-2019-02781 for details pertaining to the reportable related event.

Manufacturer Narrative

Concomitant medical products: product id 748295, serial# (b)(4), implanted: (b)(6) 2008, product type extension.Note that extension (b)(4) was initially reported, but additional information indicates this is incorrect and (b)(4) is the correct serial number.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information (including product return) has been received which has confirmed that (b)(4) was mistakenly reported.(b)(4) is the correct extension, and it was returned to medtronic for analysis.Concomitant medical products: product id 748295, serial# (b)(4) implanted: (b)(6) 2008, explanted: (b)(6) 2019, product type extension, product id 748295, serial# (b)(4) implanted: (b)(6) 2008, explanted: (b)(6) 2019, product type extension, product id 64002, lot# 0216670438, explanted: (b)(6) 2019, product type adapter.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information clarified that the impedances were better at this time.

Manufacturer Narrative

Month and year are known, but exact date is not known.Month and year of below implant dates are known, but exact date is not known.Concomitant medical products: product id 748295, serial# (b)(4), implanted: (b)(6) 2008, product type extension, product id 748295, serial# (b)(4), implanted: (b)(6) 2008, product type extension, product id 64002, lot# 0216670438, explanted: (b)(6) 2019, product type adapter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

D11: product id 748295 lot# serial# (b)(6), implanted: (b)(6) 2008, explanted: (b)(6) 2019.Product type extension product id 748295 lot# serial# (b)(6), implanted: (b)(6) 2008, explanted: (b)(6) 2019.Product type extension product id 64002 lot# 0216670438 serial# implanted: explanted: (b)(6) 2019.Product type adapter h3: the returned extensions (serial nos: (b)(6) ) were subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The extensions were returned segmented; there was no impact to electrical functionality.The returned adaptor (lot no: 0216670438) was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the #1 and #4 conductors were broken in the body of the adaptor within 10 cm of the connector area.H6: method code 4118 no longer applies, code 10 has replaced it.Result code 3233 no longer applies; code 213 applies to the extensions and 3252 to the adaptor.Conclusion code 11 no longer applies; code 67 applies to the extensions and 4315 to the adaptor.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

Concomitant medical products:product id 748295 lot# serial# (b)(4).Implanted: explanted: product type extension product id 748295 lot# serial# (b)(4).Implanted: explanted: product type extension product id 64002 lot# 0216670438 serial# implanted: explanted: product type adapter 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 reported that the patient's extensions were explanted due to an impedance failure with random results.It was unknown if there were any external factors that led to the event.It was reported that the issue was resolved at the time of the event; however, it was previously stated the issue had not been resolved, so the patient outcome is not clear.Follow-up will be performed to clarify this information.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8907646
• MDR Text Key: 155210405
• Report Number: 3007566237-2019-01785
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; "SEE H10...."; "SEE H10...."; "SEE H10...."; "SEE H10...."
• Patient Outcome(s): Required Intervention