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

Model Number B35200

Device Problems High impedance (1291); Unintended Collision (1429)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2024

Event Type  Injury  

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name ; product id 748251 (serial: (b)(6); product type: 0191-extension; implant date (b)96) 2007; explant date (b)(6) 2024; brand name ; product id 64002 (lot: n347789); product type: 0179-adapter; implant date (b)(6) 2013; explant date (b)(6) 2024 brand name activa; product id 3387s-40 (lot: v011222); product type: 0200-lead; implant date (b)96) 2007.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 reported experiencing return of symptoms after experiencing several falls.Patient's generator was replaced (b)(6) 2023 and was found to have 7 months remaining so he opted for perceptic.It was discovered that he has possible open circuits on his left 3387 lead monopolar contacts 0-3.A new battery, pocket adaptor and extension were implanted and tested but that did not resolve the out of range impedance issue.The issue was not resolved.

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

Additional information received from the manufacturer¿s representative reported the patient was scheduled for left lead revision on may 13th.On the ct, the surgeon shared the observed a fracture located in the distal portion of the left lead.The lead was partially explanted (the most distal portion was scarred down, and the surgeon was unable to completely explant).A new lead was implanted.Intra-operative testing was performed as well as an impedance check which showed all impedances were within range.In recovery, the patient¿s system was turned back on (the left stn was turned on a very low setting of 1 ma as requested by the physician), and the patient reported feeling less rigidity.

• 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: 19203816
• MDR Text Key: 341295126
• Report Number: 3004209178-2024-09945
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• 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?: No
• Date Manufacturer Received: 04/22/2024
• Date Device Manufactured: 10/10/2023
• 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...
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male