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

Model Number B35200

Device Problems Difficult to Remove (1528); Connection Problem (2900); Appropriate Term/Code Not Available (3191)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: b31061, lot#: 082u17321, implanted: (b)(6) 2022, product type: accessory, product id: b3400060, serial#: (b)(4), implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type: extension.Other relevant device(s) are: product id: b31061, serial/lot #: (b)(4), ubd: 22-jun-2023, udi#: (b)(4); product id: b3400060, serial/lot #: (b)(4), ubd: 16-oct-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the hcp performed surgery to remove the extension wire with a port plug from the incision site to connect to the new lead.They grabbed it by the port plug cap and not the extension wire connection area.The port plug was still tightened into the extension port, and the top of the plug separated from the post, which was left lodged in the extension.The clear/transparent portion of the port plug post could be removed, but the metal fixation ring remained lodged in the extension port.It could not be removed.A replacement extension had to be placed during the procedure.The environmental/external/patient factors that may have led or contributed to the issue were unknown.The surgery was extended to allow for the replacement of the extension wire.The issue was resolved and the patient outcome was "no injury".

Manufacturer Narrative

H3.Analysis of the connector plug (l/n 082u17321) found the plug was damaged.Analysis of the extension (s/n (b)(6)) found the distal end connector had a damaged balseal.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 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: 14738765
• MDR Text Key: 294925256
• Report Number: 3004209178-2022-07801
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000420987
• UDI-Public: 00763000420987
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 72 KG