MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Dyskinesia (2363); Electric Shock (2554)

Event Date 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for dystonia and movement disorders.It was reported that the patient was having really bad "episodes" and a lot of bad spasms and back pain, which put him in the hospital.The caller mentioned that around the same time, the patient had pneumonia.The patient has not had this bad of spasms and movement before.The caller stated the patient checked his ins and stimulation was off.The patient was not sure how it turned off but mentioned that it happened intermittently.It was confirmed that the ins was charged and the patient does not let it go under 50% battery.The caller stated that the patient had tripped and sat on the floor but did not have any "jarring".When the patient was in the hospital, he had an some x-rays done but the symptoms and device issue started occurring days before the x-rays were taken.The patient mentioned that when he turn stimulation back on, he feels a "jolt".No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep) reporting that the clinician thinks the patient was accidentally turning himself off and that this was the cause.Actions/interventions included verifying the impedances.Reviewed instructions for charging and turn stimulus on/off with family.Asked family to document any events and report back.At this time no further action items.This was confirmed with the physician.

Manufacturer Narrative

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

Event Description

Additional information was received from a rep reporting that about 3 weeks ago, the patient noticed that therapy has been turning off by itself.Issue is occurring 4-5 times per day.Recharge data showed that the therapy is available since battery level when recharge is not at empty.When getting the report the rep got error 0x7d8877a2.They were able to exit and go back in to look at the report.

Manufacturer Narrative

Product id a610, serial# unknown.Product type software.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional stating the cause of the ins shutting off by itself was not determined.The patient was in the office to evaluate with the rep present.The ins shutting off by itself did resolve.It was clarified that the patient was hospitalized from (b)(6) 2020 due respiratory illness.It was unknown if the patient fall was caused by the device or therapy.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9597974
• MDR Text Key: 177845803
• Report Number: 3004209178-2020-01247
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 54