MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Muscular Rigidity (1968); Device Overstimulation of Tissue (1991); Dysphasia (2195); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 8840, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a manufacturer representative (rep) regarding a patient with an implanted neurostimulat or (ins) for parkinsons dual and movement disorders.The caller reported that the clinician programmer malfunctioned and changed the patient's settings on it's own during an appointment on (b)(6) 2018.The caller reported the clinician programmer screen was not in a programming session and without anyone clicking any buttons the patient's settings skyrocketed and the patient started being shocked.The caller reported that the antenna was over the patient's implant when the issue occurred and the healthcare provider (hcp) was showing the patient how to perform an exercise, and all of a sudden the patient looked like they were having a stroke.The caller reported that the patient's left eye rolled back in their head, the left side of their mouth contorted and pulled really tight, their left hand clenched up like a fist and couldn't be loosened, and their leg tightened up extremely badly so there was no shaking whatsoever.The caller reported that the patient could speak somewhat, but could barely be understood; however the caller stated that the patient wasn't slurring words which was why they knew it wasn't a stroke.The caller reported that while the patient was having the symptoms, they ran over to the clinician programmer and it had a warning screen, the charge density screen, which said "warning, settings are at a level that could cause brain tissue damage." the caller reported that the clinician programmer needed to be rebooted to get back to where it needed to be and then the hcp then lowered the patient's settings until the patient was normal again.The caller reported that they didn't remember the other settings, but recalled that the patient was at 120v.The caller reported that the patient seemed fine once the hcp lowered the settings.The rep called on 2018-05-15 and reported that the hcp had contacted them requesting the clinician programmer be replaced because it started making changes to the patient's stimulation while it was not connected to the patient's device.The rep indicated that this event occurred on (b)(6) 2018 which conflicts with the event date reported by the initial caller.As a result it is unknown exactly when this event occurred.A replacement clinician programmer was sent to the hcp.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id: 8840, serial# (b)(4), product type: programmer, physician.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep).The rep reported that the patient was seen within the last week and was fine.The rep reported there was no stroke and the patient seemed to be receiving good therapy.The rep reported the cause of the event was undetermined no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Section 'device' information references the main component of the system and other applicable components are: product id: 8870, serial# unknown, product type: software; product id: 8870, serial# unknown, product type: software.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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7541547
• MDR Text Key: 109165151
• Report Number: 3004209178-2018-11797
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2019

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: 10/28/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 06/07/2018; 08/16/2019
• Supplement Dates FDA Received: 06/25/2018; 08/16/2019
• Date Device Manufactured: 12/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR