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

Model Number 37602

Device Problems High impedance (1291); Unintended Collision (1429); Insufficient Information (3190)

Patient Problems Therapeutic Response, Decreased (2271); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 7482a51, serial#: (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2020, product type: extension.Other relevant device(s) are: product id: 7482a51, serial/lot #: (b)(4), ubd: 09-apr-2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp), via the manufacturer¿s representative (rep), who reported after a fall the patient lost therapy.An impedance check was performed which showed values of over 40,000 on all combinations but one.The neurologist programmed the patient to the only good contact until surgery could diagnose and fix the issue.Surgery took place on (b)(6) where the neurosurgeon tested the lead with the alligator clip cables and visually inspected the extension and generator.The lead was tested and all contacts were within normal limits, but the extension showed signs of trauma near the header (generator) connection area.The neurosurgeon replaced the faulty parts (the extension and neurostimulator) and the issue was resolved.

Event Description

Additional information was received from the manufacturer representative (rep) that the extension that was returned is the extension associated with the high impedances.The surgeon only explanted one of the patient's two extensions and intra-op testing showed that the issue was cleared up.

Manufacturer Narrative

D10: section d information references the main component of the system.Other relevant device(s) are: product type extension product id 7482a51 lot# serial# (b)(6) product type extension h3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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

The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.The extension was found broken.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: 10762103
• MDR Text Key: 213867125
• Report Number: 3004209178-2020-18978
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864207
• UDI-Public: 00643169864207
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; "SEE H10...."; SEE H10
• Patient Outcome(s): Required Intervention