MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number 37601

Device Problems Break (1069); High impedance (1291)

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

Event Type  malfunction  

Event Description

It was reported that the nurse called stating patient (pt) was at eri and had scheduled for implantable neurostimulator (ins) replacement but the healthcare provider (hcp) stated there possibly was an impedance issue on the right lead.Circumstances to the impedance issue were unknown as there were no details on actual impedance issue.Troubleshooting was done.They were advised to program around impedance issue if possible.The manufacturer representative (rep) will follow up with hcp at scheduled replacement surgery.The issue was resolved at time of report.Additional information was received from the manufacturer representative (rep).The cause of eri was due to normal usage and was replaced.The impedance issue was due to damage of the cranial lead.This appeared to be at the site where the boot was tied with silk to hold it in place.There was an acute bend in the lead and the silicon was damaged.The cranial lead was tested with a twist lock screening cable, open circuit was determined.It was closed back up.The patient was not eligible for new cranial lead because of advanced parkinson's disease.Stimulation was turned off on the right side.The eri resolved, the impedance issue and fractured lead was not resolved.No surgery was planned.

Manufacturer Narrative

Concomitant medical product: product id 3389s-40 lot# v266792 implanted: (b)(6) 2009; product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(6), ubd: 01-oct-2011, udi#: (b)(4).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.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: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17273910
• MDR Text Key: 318742231
• Report Number: 3004209178-2023-12230
• Device Sequence Number: 1
• Product Code: MHY
• 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
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/06/2023
• Date Device Manufactured: 10/25/2018
• 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 Sex: Female
• Patient Weight: 85 KG