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

Model Number 37603

Device Problems Environmental Compatibility Problem (2929); Insufficient Information (3190)

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

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

See regulatory report #3004209178-2019-13497 for other implantable neurostimulator involved in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for the treatment of parkinson¿s dual and movement disorders.The patient reported she had back surgery to have 3 vertebrae fused in (b)(6) 2019 and the patient thought they might have "fouled up" the deep brain stimulation (dbs) because since that time, her parkinson's had been worse.During the call the patient initially thought the amplitude was stuck at 4.0 but patient services resolved the issue with patient programmer (pp) education.The patient was redirected to follow up with the hcp for a possible device check and to address the symptoms.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that they wanted to increase stimulation due to a gradual return of symptoms in leg.When they tried to increase the group a stimulation from 4.60 on the right side, they described that they were getting the upper limit reached on the patient programmer (pp).They stated the doctor "just did that" and verified that it was done about a year ago or so.The patient was redirected to their healthcare provider (hcp) and reviewed "upper limit reached".They also stated that they had a back surgery, which they stated the surgery was not related to the device.They fused 3 lumbar vertebrae and they feel that surgery "fouled up the dbs stimulation'.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id: 37603, serial# (b)(6), implanted: (b)(6) 2018, product type: implantable neurostimulator.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 circumstances that led to the ¿fouled up dbs stimulation¿ as 3 fused vertebrae with neuromonitoring.The patient went to their neurologist, but the issue didn¿t resolve.They wanted an mri to see if it was the fusion.The neurologist told them to turn the left side to 3.6 for 3 days and then spike it to 4.6.They said ¿if there was no difference than it was not the parkinson¿s.¿ see general text for omitted information.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8790003
• MDR Text Key: 151022311
• Report Number: 3004209178-2019-13503
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761088
• UDI-Public: 00613994761088
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 67 YR
• Patient Weight: 60