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

Model Number 37612

Device Problems Energy Output Problem (1431); Low impedance (2285); Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Tingling (2171); No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received by a manufacture representative (rep) via a healthcare professional (hcp) regarding an implantable neurostimulator (ins) for the treatment of dystonia and movement disorders.It was reported the patient programmer had an out of regulation (oor) message when the rep went to interrogate the ins to check her battery level.No troubleshooting was done prior to the call.During the call the oor message was cleared and the patient stated the ins battery was 100% full.No out of range impedances were reported.Troubleshooting resolved the reported issue.The oor did not reappear when the ins was checked.No symptoms or complications were reported or anticipated.Additional information was received from the patient indicating they were getting an oor message again on their patient programmer.They were checking their ins battery last night to see if it needed to be charged when they first noticed the oor message.The ins battery level was at 75%.The patient further clarified that "only the right one" was showing the oor message.The patient confirmed they have not had any recent trauma or falls.They have an upcoming doctors appointment on (b)(6) 2019.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep indicating the impedances were checked today and the 0-2 pair was at 54 ohms, all the other impedances were normal and therapy impedance was 954 ohms.The caller reiterated that the patient was reporting their right ins was draining quickly.The right ins was on 50% of the time, while the left was on 100% of the time.The caller inquired why the oor keeps coming up on the patient programmer.The patient was also reporting intermittent tingling at the connection site behind their right ear that comes and then goes quickly.

Manufacturer Narrative

Updated from product problem to adverse event and product problem.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep indicating the patient was to have a revision on (b)(6) 2019.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep indicating they saw the patient on (b)(6)2019.The patient had a short on a contact that was being used.It was assumed that the oor was being caused by the short, and the frequent charging was also due to the short.The physician reprogrammed the patient at the time of using a different contact.The patient was told to report if this reprogramming did not help.The rep has not heard from the physician or the patient since that time.At this time, it appears the reprogramming resolved the issue.No further complications were anticipated.

Manufacturer Narrative

D2: please note that this device was used in an off-label manner as it was implanted for dystonia.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: 8776973
• MDR Text Key: 150680222
• Report Number: 3004209178-2019-13229
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/10/2020

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: 12/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 07/15/2019; 07/31/2019; 07/26/2019; 08/21/2019; 11/10/2020
• Supplement Dates FDA Received: 07/23/2019; 07/31/2019; 08/12/2019; 09/03/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 45