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

Model Number 37612

Device Problems Low impedance (2285); Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, lot# unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was having unpleasant current sensations at the connection point on the left side of the head and a bit down their neck and out in the right arm during impedance measurements at 3.0v.They also got involuntary twitches in their right arm during the test, experienced discomfort and became drowsy afterwards.The next impedance measurement was performed on (b)(6) 2020 which showed low impedances in bipolar reading between poles 9 and 11.Repeated attempts were made to deactivate pole 9, but then the patient's therapy deteriorated sharply (more on/off problems, fatigue and leg weakness with walking problems.), so the treatment had to be changed back to amplitude they had since 2011 with + pole 9 and - pole 10.At the measurement last week electrode impedance showed low as before but had not previously received those current sensations.They performed the test during "provocation" (pressed on the connection point while the patient turned their head to the side).In tests without provocation the patient only felt a vague feeling in the area of the connection point during measurement at 3.0v.The patient had continued to have a good effect with the "old" db settings.

Manufacturer Narrative

Continuation of d10: product id neu_unknown_lead lot# unknown serial# implanted: explanted: product type lead 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 patient was back at the rehab department and had both extensions on the left side of the head.They experienced slight discomfort on the left side of the head down to the neck at 1.5v.The feeling of current increased and also gave symptoms in the right arm at 3.0v.They didn't experience discomfort in their everyday life, not a feeling of current.They tried to push over the connection point without simultaneous impedance measurement and then the patient didn't feel discomfort of feeling of current.There was no trauma or falls.The patient had good therapeutic effect with current amplitude.They had very advanced pd where their tremors became violent when dbs treatment was stopped.They repeatedly tried to deactivate pole 9, with other similar settings, but then lost good dbs effect and was too much trouble with shaking and stiffness, therefore they went back to the old settings.X-rays were taken but not yet examined.

• 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: 13404453
• MDR Text Key: 289295309
• Report Number: 3004209178-2022-01430
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2022
• Date Device Manufactured: 03/28/2018
• 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