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

Model Number 37602

Device Problem Failure to Deliver Energy (1211)

Patient Problems Muscle Weakness (1967); Muscular Rigidity (1968); Shaking/Tremors (2515)

Event Date 05/02/2023

Event Type  Injury  

Event Description

Information was received from a patient's representative regarding an external device.Patient (pt) started to do on/ok checks using their 37642 programmer starting on tuesday or wednesday last week, because they noticed leg weakness, stiffness, some jaw tremor, pt was hospitalized where a ct and blood work were done and everything looked fine and they went home but wound up at (b)(6) hospital due to their symptoms.Caller said yesterday a manufacturer representative (rep) just happened to be there and saw the patient, used their equipment and confirmed stimulation for the left ins was off, they turned stimulation back on and pt's symptoms resolved, they were released from the hospital.Caller was calling because they think the programmer showed on/ok when the ins was actually off.Caller wanted to find out how stimulation could have been off when the programmer showed on/ok.Reviewed the off button could have accidentally been pressed.Caller said it was not.Reviewed when checking 2 implants the programmer must be powered down between sides.Caller confirmed they do that correctly.Reviewed the doctor or the doctor and the rep would be the best resource to find out more information.Offered to replace the programmer and sent email to repair.The issue was not resolved.An email was sent to the repair department to replace the device.The patient's relevant medical history included caller said pt's diagnosis was rigidity and dyskinesia but pt had no tremor.Caller said pt has had dbs since 2004 and sometimes the reps would tweak it and the patient would get a little bit of tremor but caller did not know the reps name nor the dates for the events.

Manufacturer Narrative

Continuation of d10: product id 37602, serial# (b)(6) implanted: (b)(6)2022, product type: implantable neurostimulator; product id 37642, serial# (b)(6), product type: programmer, patient.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.If information is provided in the future, a supplemental report will be issued.

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 received from the healthcare provider (hcp) reported the cause of stimulation being off wasn¿t determined.St imulation was turned back on which resolved the issue.

• 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: 16905474
• MDR Text Key: 314939975
• Report Number: 3004209178-2023-06238
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000519223
• UDI-Public: 00763000519223
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2023
• Date Device Manufactured: 12/23/2021
• 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 Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 75 KG