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

Model Number 37603

Device Problems Break (1069); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot#: va1jge6, implanted: (b)(6)2017, explanted: (b)(6) 2018, product type: lead.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: extension.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 01-jun-2020, udi#:(b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 04-aug-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported the chiropractor manipulated the extension during treatment that caused the extension to twist repeatedly and fracture.The fracture pulled the contacts off the end of the lead and were stuck in the extension.It was reported there was no fault of the product and the patient was fine with great therapeutic benefit until the chiropractor visit.After, the patient experienced a loss of therapy and tremor control.After checking the impedances, conducting a chest radiograph, and an exploratory surgery, the patient underwent a complete system explant on (b)(6) 2018.The issue was resolved at the time of the report and the patient will be replanted.The patient was alive without injury at the time of the report.No further complications were reported or anticipated.

• Brand Name: ACTIVA
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7560243
• MDR Text Key: 109760695
• Report Number: 3004209178-2018-12332
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• Date Device Manufactured: 08/30/2017
• 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
• Patient Outcome(s): Required Intervention