MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37603

Device Problems Break (1069); High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Pain (1994); Dyskinesia (2363); Numbness (2415); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2019

Event Type  malfunction  

Event Description

It was reported that patient is having issues with left side, leg cramps, struggling with walking, walking on tip toes because leg hurts.Keeping right leg stiff and not bending it.Left side issue and foot numbness was first noticed in 2012 and was diagnosed with parkinson's.Last several months symptoms have gotten worse.Patient is on 100ml gabapentin and its not helping at all and patient is not sure he can continue to work because of symptoms.Patient saw doctor on (b)(6) 2022 and patient was led to believe that the leg issues were not due to the parkinson's.The doctor wanted to do a mri but mri facility told doctor they could not do the mri.Caller states in (b)(6) 2019 when it was time to replace the ins, it was noticed the lead had been broke.They did not feel the need to fix it.Caller is wondering if this could be why.Caller pulled up patients "my chart" it said, patient states having left leg cramping about 2 months ago.It can move around back of leg and calf, it occurs with activity.When it kicks in it varies.Patient finds if he sits down to rest it goes away.Patient has adjusted dbs but that did not seems to do anything.Not foot curling.Patient states leaning over to do something and it started hurting.No numbness, no "worseness" dyskinesia, right leg tends to stiffen up to compensate for left leg.Bending forward does not help.This has compounded his gate issues, pt has also struggled with dyskinesia.He is now struggling more at work and taking frequent breaks.My chart also read doctor was looking into open circuit dbs and emg.Caller states doctor wants patient to do physical therapy but it is 2 hours away so patient does not want to do it.Patient services redirected caller to mri facility or doctor to confirm reason for not being able to do mri.

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, serial# unknown, implanted: (b)(6) 2013, product type: lead.Other relevant device(s) are: product id: 3389s-40, 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

Additional information received from the healthcare provider (hcp) reported the symptoms were not dbs related.The lead was broken but there was an open circuit at bipolar 1:2 that wasn¿t being used.The hcp wanted to confirm it was okay to have an emg if there was an open circuit.

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: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 13562161
• MDR Text Key: 296258983
• Report Number: 3004209178-2022-02261
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/12/2023
• Date Device Manufactured: 02/28/2019
• 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 Age: 54 YR
• Patient Sex: Male