MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Intermittent Continuity (1121); Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 11/13/2019

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 their implantable neurostimulator (ins) for parkinson's disease and movement disorders it was reported that the patient's care giver was using the patient programmer (pp) last night to check the charge of the patient's ins and noticed that the ins was showing off.It was stated that on the day prior , the ins was on when they checked it.The care giver turned the ins back on and the patient experienced a "horrible jolt", and they turned it back off.It was mentioned that this morning the patient was paralyzed so the caregiver turned the ins back on, noting that the "jolt" eventually subsided on its own and now the patient was doing okay.Potential causes of the ins being off were reviewed and the caregiver stated that the patient's ins battery was about half way yesterday.It was also reported that patient had x-rays done of their leg and would be getting another x-ray soon.It was stated that the doctor set the ins to "2.7 over 3.9," noting that the settings haven't been changed.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the patient was not paralyzed.The system turned itself off, about 4 times over the course of a few weeks.The patient's body could not function.When it was turned on again , the patient got a significant jolt each time.It was indicated that the patient cannot get to the stimulator, therefore no one turned it off.It turned off on its own.

Event Description

Additional information was received where it was clarified that the "jolt" would be experienced a couple seconds and it would then go away.The patient met with the neurologist and the healthcare provider (hcp) recommended removing the batteries from the patient programmer (pp) to save on the battery and to not turn off the implant.They reported the assisted living facility charges the ins every two weeks and the hcp was requesting the ins get charged twice a week.The battery status was at 100%.It was reviewed and recommended to keep the ins charged up and that if the ins depleted therapy would stop.The basic function of the pp was reviewed along with recharging best practice and functionality of battery removal.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was stated that patient never indicated being paralyzed.It was reported that when the dbs gets turned on, there is a brief jolt and the problem was the care home did not charge the dbs long enough or frequently enough, and this was not the fault of the equipment.

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: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9335900
• MDR Text Key: 176635544
• Report Number: 3004209178-2019-22012
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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,Followup,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 66