MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Battery Problem (2885)

Patient Problems Memory Loss/Impairment (1958); Therapeutic Response, Decreased (2271); Malaise (2359)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient needs to charge his implantable neurostimulator (ins) 3x/day because his neurologist set him on a high voltage, but they reported they are not able to charge because the recharger is "broken".They stated their symptoms returned and they are "very sick" and "very unwell" because they have not been able to recharge.The caller stated that they get error cod 376, the thermometer screen, and the reposition antenna screen when they switch the recharger's antenna to another recharger.They noted both recharger's do not work.They stated they have a very bad memory.Additional information was received from the patient.It was reported that patient was seeing a system set up screen message on his recharger.Patient was charging his implantable neurostimulator (ins) when the message popped up.Patient stated that he has a 50% battery left in ins and that will only allow him to use stimulation for 3 more hours.Patient was advised to try to reset the recharger which patient had already done but we tried a 2nd time.Patient stated the message is the same.It was reviewed for the patient that with this message, the recharger will need to be replaced and the he will need to work with his managing health care provider (hcp) on getting the replacement recharger or help with charging of his ins.It was also explained to the patient that an email will be sent to the team in australia asking for assistance of the patient.It was stated that the patient only had a 1/4 battery left and will be left incoherent if this recharger doesn't get fixed soon or he gets charged up.It was also reported that a while ago, he lost stimulation and was hospitalized for 1 week but was not provided a replacement recharger to use.Patient stated that no one can work with him due to liability and that no one knows how to work with the stimulators for ocd.Patient was informed that he needed to seek care and contact a managing hcp based on the information he provided considering if therapy is to turn off imminently.Additional information was received from the patient stating that he had received the charger, the charger was sitting on his chest recharging him perfectly.It arrived in perfect condition and patient was so relieved to be charged up again.Therefore the manufacturer's representative (rep) stated that there was no need for further support.

Manufacturer Narrative

G5: please note that this device was used in an off-label manner as it was implanted for obsessive compulsive disorder (ocd).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.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10258476
• MDR Text Key: 201666183
• Report Number: 2182207-2020-00503
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

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 Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization