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

Model Number 37601

Device Problems High impedance (1291); Battery Problem (2885); Material Deformation (2976)

Patient Problems Muscular Rigidity (1968); Twiddlers Syndrome (2114); Neck Stiffness (2434); Twiddlers Syndrome (4563)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2020, product type: extension.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 06-jul-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that upon interrogation of the implantable neurostimulator (ins), the battery voltage showed 2.72v and ins is off at end of service (eos).They reported from last interrogation in (b)(6) showed 2.89 v with status of ok and the patient never saw elective replacement indicator (eri) or eos.They stated that contact 3 has high impedances but the rest are in range.Left stn: c-0 817, c-1 916, c-2 739, 0-1 1361, 0-2 1485, 1-2 1292, all pairs with 3 were high; right stn: c-8 715, c-9 829, c-10 653, c-11 1133, 8-9 1233, 8-10 1151, 8-11 1825, 9-10 1189, 9-11 1971, 10-11 1431; the patient is programmed on c-1 and c-9.The manufacturer representative (rep) asked the patient about recent falls or shocking and nothing was reported.Group usage showed (b)(6) with 100% usage of group a but (b)(6) only shows 20% usage of group a, so likely the ins turned off sometime this month.The patient reported the wire in their neck feels like it is pulling and pointed to the lead/extension connection behind the ear where it was feeling funny and tight.The rep felt the area and confirmed it did feel "pretty taut".It was unknown how long this feeling has been occurring.It was suggested to image the system, check impedances in various positions, and intra-op impedance testing of the leads/extensions.Potential intermittent short and that the ins has to be replaced at this point since eos has flagged but that voltage likely bounced back from ins being off was reviewed.Additional information was received from a manufacturer representative (rep) reporting the cause of the high impedance and eos at 2.72v was undetermined.No actions are taken yet and the issue is unresolved at the moment.Additional information was received from a rep reporting that the patient is getting a battery replacement today and because of the high impedance, the surgeon will also replace the left extension only today.There were no falls or damaged reported and no patient harm.The patient's therapy was not affected.Additional information received from the manufacturers representative (rep) reported they only replaced the battery for the patient, not the extension as they stated previously.Upon opening the pocket of the patient, it was found the extensions were extremely twisted/coiled and had likely been spun around by the patient and the cause of the high impedance.The high impedances resolved on contact 3 when the surgeon untangled the extension wires, but a new high impedance appeared on contact 11.This contact was not in use by the patient and would not affect therapy.It was noted the patients battery also showed end of service (eos) while the battery was at 2.8 volts.

Manufacturer Narrative

H3.Analysis of the ins (s/n: (b)(6)) found the battery was at end of service (eos) or elective replacement indicator (eri) and the ins did not meet expected longevity; cause unknown.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: 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
• MDR Report Key: 10678242
• MDR Text Key: 219513814
• Report Number: 3004209178-2020-17923
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; SEE H10
• Patient Age: 76 YR
• Patient Weight: 95