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

Model Number 37603

Device Problem Electromagnetic Interference (1194)

Patient Problem Ambulation Difficulties (2544)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced difficulties walking/ balancing (specifically shuffling feet) during the afternoon of (b)(6) 2020.These are symptoms the patient experienced pre-dbs due to his parkinson's disease.Patient also mentioned falling that evening as well.Earlier that day (around 2:37 pm), patient came to hospital for an mri scan.On (b)(6) 2020, patient received an mri which did not exceed 30 minutes per the medtronic labeling.On (b)(6) 2020 impedance checks were performed on both left and right implantable neurostimulators (ins) prior to the scan.Both monopolar and bipolar electrode impedance measurements were in range.Therapy impedance measurements were also within range.For the mri scan, patient was switched from a monopolar to a bipolar mode for the right ins.(group a to group b).Patient did not switch groups for the left ins for the mri scan.Patient was receiving therapy from group c (already in bipolar mode).These settings align with medtronic's guidelines for mri-compatibility based on his implanted devices.Referring to reports generated on medtronic tablets, after mri scan the patient was switched from group b back to group a for the right ins.On (b)(6) 2020 impedance checks were performed again on both left and right ins's, electrode and therapy impedance measurements were in range.His groups were the same as pre-mri scan on (b)(6) 2020.Again the left ins was already in an mri-compatible setting (group c- bipolar mode).However, the patient's right ins was switched from group a to group b for the scan.After the scan, patient switched group b to group a.Another, impedance check for both left and right ins's were performed after the scan.Monopolar and bipolar impedance measurements were within range.The patient's daughter increased the left ins from 2.9 v to 3.1 v for increased stimulation/therapy.Also the patient's parkinson's medication (carbidopa levodopa) were increased.The issue was resolved at the time of the report.Additional information was received from a manufacturer representative (rep) on 2020-mar-09.It was reported that after the mri, the patient was receiving therapy from appropriate settings.The impedance checks indicated their systems are intact and working properly.It is unknown what caused the patient's shuffling/balance issues after the mri.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 9861573
• MDR Text Key: 184338042
• Report Number: 3004209178-2020-05824
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2020

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: 03/28/2017
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/20/2020
• Date Device Manufactured: 10/06/2015
• 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 Age: 73 YR
• Patient Weight: 64