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

Model Number B35200

Device Problems Break (1069); Unintended Collision (1429); Low impedance (2285)

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

Event Date 12/20/2023

Event Type  Injury  

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

Patient reports 'intermittency between groups'--agent asked what that indicated and the patient states he 'doesn't feel like the dbs is working like it used to'.Patient reports this has been the case for 3 months approximately.Mdt rep states the patient had a fall on (b)(6) 2023 (before his previous doc appt) and had another fall in january.At the last doc appt, which appears to have been around the same 3 month time span, there were no impedance issues.However, today there are impedances issues that appear to be intermittent; rep states they are 'various' and 'change'.The rep ran impedances and saw 2b 75 ohms and 1a 54 ohms.The rep states they palpated the battery and extensions and ran the impedances again and impedances 'cleared', however, when the impedance were ran again there were other segments that were 'out'.Agent reviewed they appear to have intermittent short circuits and at this juncture they can consider running further impedance tests in different positions to determine if there are any viable contacts for programming.No symptoms were reported.

Manufacturer Narrative

Section d10 references: product id b3400060m serial# (b)(6) product type extension.Product id b3400060 serial# (b)(6) product type extension.Product id b31061 serial# unknown product type accessory h3.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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

Additional information received from the manufacturer¿s representative (rep) reported the products were returned due to the extensions being damaged and there being an impedance issue.

Manufacturer Narrative

Section d10 references: product id b3400060m serial# (b)(6) product type extension.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

Additional information received from the manufacturer¿s representative (rep) reported the patient had one extension connected to the lead with the other one being ¿parked¿ for a future lead, so they didn¿t know the integrity/insulation was compromised until the operation.Short impedance values ranged from 47-294.The hcp ran impedance without any palpating, and then palpated the extension/battery connection along with up the neck at the lead/extension area.It was determined the extension was the issue and replaced on (b)(6) 2024.

Manufacturer Narrative

H3.Analysis of the extension (s/n (b)(6) found the outer insulation was separated at the tube overlap point.Analysis of the e xtension (s/n (b)(6) found the outer insulation was separated at the tube overlap point.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 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: 18979344
• MDR Text Key: 338763489
• Report Number: 3004209178-2024-07831
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2023
• 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
• Treatment: SEE H11; SEE H11
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male