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

Model Number B35300

Device Problems Charging Problem (2892); Insufficient Information (3190)

Patient Problem Paresthesia (4421)

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins).The reason for call was rep said patient reported, yesterday, that since about a week ago, patient felt tingling sensation at implant site when recharging.Patient would then turn therapy off so the sensation would not be present.Issue only occurred with one implant, although patient has bilateral implants.Rep didn't know which side had the issue.Technical services (ts) recommended recharging with a thin later of clothing, assuming patient wasn't doing that already.Discussed changing group, if that is a possibility, while recharging to see if using another group made the sensation go away.Rep to contact patient to get more information.Ts recommend getting mdt file, json file, and log files if rep were to meet with patient.The caller was not with the patient.Therapy is working as intended, per rep.Additional information was received from the manufacturer representative (rep).The cause was not determined.The tingling sensation is in her face, tongue and hand if it is kept on for a long period of time.The tingling does not occur when the patient turns her implant off while recharging.The tingling only resolved when turning the implant off when charging.This information was confirmed with the account.

• 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: 18989556
• MDR Text Key: 338752380
• Report Number: 3004209178-2024-07952
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000564346
• UDI-Public: 00763000564346
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B35300
• Device Catalogue Number: B35300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2024
• Date Device Manufactured: 12/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female