MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number B35200

Device Problem High impedance (1291)

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 02/10/2021

Event Type  Injury  

Event Description

It was reported that on 2021-feb-10, once the mer recording was performed, then the lead contacts were checked for thresholds for benefit and side effect.Thresholds checked in bipolar configuration (monopolar/bipolar) at pw of 90 and frequency of 135: contact 0: 5v, the patient could not tolerate amplitudes greater than 7v, so further ot testing was deferred.The patient experienced eyelid closing.Contact 1 and contact 2: 6.8v - patient experienced hand pulling.Contact 3: open.There was no stimulation-induced side effect up to 10v/patient experienced no side effects.The left dbs lead was uneventful.On (b)(6) 2021, the patient presented for scheduled implantation of their right side dbs lead but inspection of their recent left frontal scalp incision site showed a small dehiscence at the posterior aspect of the incision and compressing the surrounding scalp results in expression of a small amount of apparently purulent exudate.The patient elected to defer their scheduled right dbs lead implantation procedure and proceeded with elliptical excision and primary repair of the poorly healing, apparently infected wound dehiscence site with attempted preservation of the dbs hardware.There was no appreciable purulence after excision of the small area of dehiscence and no evidence of contamination of the dbs hardware.The patient was treated with antibiotics for 3 weeks and the site healed well without evidence of infection.The right dbs lead was rescheduled for (b)(6) 2021.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id 3387s-40 (lot: va2a5mj); product type: 0200-lead; implant date (b)(6) 2021; 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: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 18978469
• MDR Text Key: 338596698
• Report Number: 3004209178-2024-07814
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00763000420987
• UDI-Public: 00763000420987
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Date Device Manufactured: 01/25/2021
• 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: 43 YR
• Patient Sex: Female