MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number B35200

Device Problems Break (1069); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Muscular Rigidity (1968); Anxiety (2328); Shaking/Tremors (2515)

Event Date 03/29/2023

Event Type  malfunction  

Event Description

It was reported that this morning the patient couldn't feel one of the extensions where as previously she thought she could feel both extensions.The patient stated when she woke up this morning her neck was stiff (just because it was the morning) but that the right side of their neck has been stiff since the surgery.Patient stated they were exercising a lot yesterday (yoga  kick boxing, physical therapy, and massage) and could have done some very little twisting, but they do it delicately and patient doesn't participate in activity that involves a lot of twisting.The patient states she has anxiety from day to day and some days she will feel great and some days wont feel great.The patient states she gets body shakes and isn't sure if it's from the anxiety or from one of the extensions breaking.The patient was concerned that they could have broken one of the extension and now the extension was floating around somewhere.Agent ensured the patient that even if the extension were to break it would not coil or float freely around in the body, but would stay in the tunneling channel that was made at the time of surgery.Agent provided education to the patient on how the tunneling works for the extensions and redirected the patient to their healthcare provider (hcp).

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown.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 parkinsonian tremor
• 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: 17157392
• MDR Text Key: 318338927
• Report Number: 3004209178-2023-11243
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000642174
• UDI-Public: 00763000642174
• 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: 06/19/2023

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 Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/19/2023
• Date Device Manufactured: 03/08/2023
• 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
• Treatment: "SEE H10...."
• Patient Age: 45 YR
• Patient Sex: Female