MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number 37612

Device Problems Failure to Power Up (1476); Connection Problem (2900); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Shaking/Tremors (2515)

Event Date 05/01/2017

Event Type  malfunction  

Event Description

Information was received from a patient's representative regarding an implantable neurostimulator (ins).The caller reported that probably 5 or 6 years ago the patient felt like the dbs therapy was not controlling their tremors as much as it used to.The caller noted that the patient mainly has the tremor when they reach for something, which makes it difficult for them to eat and pick things up.The caller mentioned that the patient does not have the tremor while seated.The caller mentioned that the patient's neurologist has the ins turned up as high as it can, and the patient was told that the only option they have would be to get another ins (the caller stated that the patient does not want to get another ins at this point).The caller did mention that the dbs therapy makes a huge difference for the patient, just not as much as it did when the patient first got it.The caller added that because of the patient's tremor, they "jerk the cord loose" on the desktop charger (dtc).The caller mentioned that they have had to get the dtc replaced 4-5 times because of this.The caller mentioned that one time the dtc cord was damaged (about 4 years ago), manufacturer representative (rep) was notified of the issue at an appointment and happened to have a replacement dtc with them, which they provided to the patient.The caller mentioned that all the other previous damaged dtc cords were reported to patient services.This past thursday, the caller noticed that the recharger was not charging the patient's ins because they could not get past the 'charge your recharger' warning screen.Agent reviewed meaning of the screen, and the caller confirmed the dtc was connected to the recharger.The caller mentioned that yesterday their son noticed the dtc cord was damaged again due to the patient jerking on the cord because of their tremor.Before calling patient services, the caller mentioned that they called rep on saturday to report the damaged dtc cord, and the caller was advised to call patient services to request a replacement.The caller mentioned that the patient's ins charge level was 75%.An email was sent to the repair department to replace the dtc. caller called back and reported that they received the replacement dtc today and the green light it on it, but the recharger will not power on.Caller performed a hard reset on the recharger and that did not resolve.See secure note field for s/n.The caller also added that they had concerns because the pt programmer would not connect to the implant and only showed poor communication.Asked the caller if the ins battery could be depleted.Caller confirmed that they do not think so as when the ins battery depleted 2-3 years ago, the patient had worsening tremor and a burning tongue and that is not happening now.Advised caller to try connecting again and it did connect to the ins and showed low.Caller also noted during the call a previous instance of the pin plug breaking off of the dtc as noted in the original call.Additional information received from the manufacturer¿s representative (rep) reported the physician requested to upgrade the patient to the wireless recharger as the legacy recharger was difficult for the patient to use due to their age.

Manufacturer Narrative

Continuation of d10: product id 37751 lot# serial# (b)(6) product type recharger.Section d information references the main component of the system.Other relevant device(s) are: product id: 37751, serial/lot #: (b)(6), ubd: , udi#: h3: analysis of the 37751 recharger (rtm) (serial number (b)(6)) revealed bent connector pins.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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.

Manufacturer Narrative

Concomitant medical product: product id 37761, serial# (b)(6) product type recharger product id 37751, serial# (b)(6) product type recharger h3.Analysis was performed on [product id 37761 serial# (b)(6)] analysis found that the cable assembly connector pin was bent.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 18632453
• MDR Text Key: 334800273
• Report Number: 3004209178-2024-03375
• Device Sequence Number: 1
• Product Code: PJS
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2010
• 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 Age: 85 YR
• Patient Sex: Female