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

Model Number 37601

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

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Visual Impairment (2138); Dysphasia (2195); Insufficient Information (4580)

Event Type  Injury  

Event Description

The patient reported that prior to surgery ¿the patient¿s main eye could open¿ and that they had torticollis and their head was thrown back while speaking and that after implant the patient¿s postoperative torticollis had improved significantly.However, ¿in the second week after the boot, the eyes could not open¿ and the patient experienced ¿pain around the forehead when speaking or exerting force.If the patient¿s eyes could open their neck would swing left and right.The patient ¿could not speak clearly, had difficulty swallowing,¿ and their ¿expression was rather ugly.¿ the patient returned to the hospital for programming once a week, but it had not improved.It was unknown whether any effective measures had or would be taken or what troubleshooting was performed.The patient was at home at the time of report and was seeking a better solution.No further complications were reported or anticipated.It was reported that due to the patient's poor post-operative effect and pain at the ins site, the ins and extensions were explanted.

Manufacturer Narrative

Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 16-sep-2025, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 16-sep-2025, udi#: (b)(4).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: 15233099
• MDR Text Key: 297964535
• Report Number: 3004209178-2022-10378
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000384326
• UDI-Public: 00763000384326
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2022
• Date Device Manufactured: 06/29/2021
• 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): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female