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

Model Number B35200

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Patient Device Interaction Problem (4001)

Patient Problem Electric Shock (2554)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported that patient (pt)  experienced shocking sensation when head was in various positions.Impedances in those positions were low.In a previous surgery, the extension to battery connections were checked, then the extension was replaced.The symptoms continued, so it was determined that the lead needed replacement.The lead replacement occurred this week.After the lead was replaced, all impedances were normal.As of right now this issue is resolved.The cause of the low impedances may be due to a fall where the patient hit their head.The issue was resolved.Additional information was received from the manufacturer representative (rep).The cause of the impedance issue was undetermined, but believed to be an impact to the head.

Manufacturer Narrative

Continuation of d10: product id neu_unknown_ext lot# serial# unknown, product type extension product id 3387s-40, lot# va1nzf1, implanted: (b)(6) 2018, explanted: (b)(6) 2024, product type lead section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown; product id: 3387s-40, serial/lot #: (b)(6), ubd: 03-jul-2020, udi#: (b)(4) h3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the outer insulation was separated in the body of the lead; consistent with explant damage.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.

Manufacturer Narrative

H3.Analysis of the lead (l/n va1nzf1) found no significant anomaly.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.

• Brand Name: PERCEPT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 18840642
• MDR Text Key: 336931181
• Report Number: 3004209178-2024-06313
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000519216
• UDI-Public: 00763000519216
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 64 KG