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

Model Number 37603

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial#: (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a distributor via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for unknown indications for use.The patient developed symptoms of their underlying disease during normal use, so the ins was checked with the programmer.The programmer confirmed the ins was turned off.It was noted the patient used a microwave oven and telephone poles near the patient's home were dense.An appointment with the physician was scheduled.The event was not resolved a the time of this report.No further patient symptoms/complications were reported as a result of the event.

Manufacturer Narrative

Product id 37603 lot# serial# (b)(4) implanted:(b)(6)2013 explanted: product type implantable neurostim ulator if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was confirmed from the patient that the environment was not considered to be the cause of the power turning off.There were only general household appliances such as microwave ovens and refrigerators at home, and the main worry was that there were many telephone poles around the patient's home.The patient did not visit areas of high voltage, the issue did not occur when passing through anti theft gate, and no mri or ct scan was performed.It wasn't clear if the event had been resolved, but he patient had an appointment on (b)(6)2019 planned to investigate the issue and data from the device will be obtained then.An impedance readout showed that impedances were with normal limits.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received indicating there was no troubleshooting / diagnostics performed.The patient noted on (b)(6) 2019 they passed through an anti-theft gate at a supermarket before the event occurred.

Manufacturer Narrative

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.

Event Description

Additional information was received indicating the issue has since resolved.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9130937
• MDR Text Key: 160475379
• Report Number: 3004209178-2019-18578
• Device Sequence Number: 1
• Product Code: MHY
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 10/02/2019; 11/19/2019; 11/20/2019
• Supplement Dates FDA Received: 10/17/2019; 11/19/2019; 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1