MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Weakness (2145); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544); Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37612, serial#: (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a healthcare professional (hcp) via manufacturing representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the rep got an email from the doctors office that stated the patient had recent falls and was now experiencing electrical shocks and weakness.The sensation started on the left and goes down the back.The patient felt the sensation at the time of the appointment with the rep and when the patient was moved from the bed, she felt shocking sensation.The patient did not feel shocking when the device was off.The patient was having a complete return of symptoms and a hard time walking.Impedances were taken and showed the following: right side, the patient is programmed for therapy using electrodes c+ 2- c0 1747 c1 1722 c2 1171 c3 1764 01 2507 02 2321 03 3319 21 2028 31 2125 32 1977 left side.The patient is programmed for therapy using electrodes c+ 2- c0 1926 c1 1611 c2 1368 c3 1543 01 1811 02 2343 03 2828 21 1590 31 2278 32 1568.The rep mentioned that she had seen issues where the pocket adaptor pulled away from the ins and caused impedance issues.No further complications were reported/anticipated.

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.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 9940418
• MDR Text Key: 188590092
• Report Number: 3004209178-2020-06905
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."