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

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Spasm(s) (1966); Muscular Rigidity (1968); Scar Tissue (2060); Neck Stiffness (2434); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 11/16/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), udi# (b)(4).Date of event: the event date is estimated.The aware date is estimated.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient is due to have his second surgery for his deep brain stimulation because the connection between the implanted neurostimulator battery and the lead that goes behind his right ear is "so tight." patient said he noticed this issue 2-3 months after implant date.The patient stated they were calling to get in contact with the rep to help make arrangements for the surgery.The patient stated he called the rep and left messages for him last week and this morning but has not heard back.Additional information was received from a manufacturer representative (rep) reporting the patient had stage 1 on (b)(6) 2019 and stage 2 on (b)(6) 2019.The rep was present for both cases and it all went very well.The rep recalls at least two programming sessions at the end of 2019, which went well with no complaints.The rep was contacted at some point in early 2020 and helped reprogram the patient.The patient was doing well with their settings with good symptom control, deep brain stimulation (dbs) integrity in good working order, but was complaining about neck tightness at that time.They did show some spasm and neck stiffness.The healthcare provider (hcp) was notified.Due to covid, the rep was unable to see the patient but spoke with the patient later and the patient was still complaining of neck stiffness.The hcp was recommended to refer back to the surgeon for assessment with possible consideration of a revision of the extension or to possibly free up the extension from possible scar tissue that may be causing the issue.The rep believes the referral was made but not scheduled due to waiting for insurance approval.The patient's dbs system is doing well with controlling the patient's motor symptoms with exception of neck tightness.

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 was received from a manufacturer representative (rep) reporting the patient was scheduled for a pocket revision to loosen up the extension and this was completed monday, (b)(6).The rep interrogated the battery prior to the procedure and appearances were normal and the patient was getting good therapy.During the case, the physician freed up the extension and cut out scar tissue that was binding down on the extension loop.They made the pocket a little deeper and put a little more slack pulled up.It seemed to resolve the issue.Physical therapy was recommended to work on their neck range of motion.

• 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: 10743729
• MDR Text Key: 215975397
• Report Number: 3004209178-2020-18782
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR