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

Model Number B35200

Device Problems Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2023

Event Type  malfunction  

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

Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins).The call was because the rep said the patient had ins replacement on (b)(6) 2023, and everything was fine with the new ins in place.The next day, the patient connected to ins and immediately received a 1703 message.The caller indicated that the patient was on typical dbs settings, nothing extraordinarily high.The caller was not with the patient.Tss reviewed 1703 means out of regulation (oor) message likely due to an impedance issue and suggested that the caller meet with the patient to interrogate ins.  (b)(6) 2023  rtg0526431 follow-up on call to tech services (rep): additional information was received from technical services informing the rep that if the replacement workflow was used to transfer settings from pc to percept, the pocket adaptor information doesn't always transfer smoothly.Ts suggested the rep check the setup/configuration information, ensure that the pocket adaptor was listed and the leads/electrodes numbered correctly, and then check impedances. additional information was received from the rep that the impedances were fine in the or, and they asked if that eliminated the potential cause of the issue indicated by ts.Ts reviewed they wouldn't expect the pocket adaptor information to be incorrect (a good impedance check would support this).However, knowing the pocket adaptor information doesn't always transfer smoothly, they want to confirm everything in the configuration is correct.

• 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: 18460480
• MDR Text Key: 332736587
• Report Number: 3004209178-2024-00330
• Device Sequence Number: 1
• Product Code: MHY
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/05/2024
• Date Device Manufactured: 11/07/2023
• 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 Age: 79 YR
• Patient Sex: Male