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

Model Number B35200

Device Problem Unintended Collision (1429)

Patient Problems Muscle Weakness (1967); Dysphasia (2195); Ambulation Difficulties (2544)

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported that the patient fell and after that was feeling very weak to where one side of their body started giving up.Patient hadn't been able to speak or move so caller brought patient to primary care doctor and hcp told patient to go to the hospital where patient currently resides.The circumstances that led to the reported issue were asked but unknown.The patient was redirected to their healthcare provider to further address the issue.Hcps are currently doing further investigation of what caused the issues the patient was having.Patient will be getting mri.Caller said they didn't think the issues were device related but that they didn't know if that was the case yet.

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.

• Brand Name: PERCEPT
• 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: 14625627
• MDR Text Key: 294119501
• Report Number: 3004209178-2022-07300
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000420987
• UDI-Public: 00763000420987
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/07/2022
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male