MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B35200

Device Problems High impedance (1291); Application Program Problem (2880)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2022

Event Type  malfunction  

Event Description

It was reported that the manufacturer's representative was in the operating room (or) for implantable neurostimulator (ins) replacement and after implanting new percept, impedances were all over the board.The caller stated there were no impedance issues pre-operatively.Caller stated they already done extensive troubleshooting; ins in and out of pocket, wiping down extensions, running stim through programmed contacts, ran impedances manually at 1.0 ma, etc.And every time the contacts with issues and the impedances values change.Caller ran impedances a few times and they continued to change on the call.It appeared that on the left side, contacts 0 and 2 and on the right side, 8 and 10 were consistently in range but all other pairs were under 10k ohms, with values around 6000-7000 ohms.The caller stated patient was programmed on 0-1 (showing 7530 ohms) and 8-10.The issue was not resolved through troubleshooting.Technical services (ts) reviewed that it was unclear what the issue was but that they aren't completely out of range and could normalize post-operatively or in the coming days.Ts reviewed that if no further troubleshooting can be done at this time (hooking extensions to ens, opening lead/extension site) then everything can be left as is with percept implanted and see if impedances change after the procedure.Ts suggested placing extensions back into previous ins to see what impedances were but hcp declined.Additional information was received from the healthcare provider (hcp) who reported high impedances and a bad surgical case that occurred on friday.The clinician indicated patient was eri and all impedances were normal prior to ins replacement.The caller reported the following impedances also reported during surgical procedure.L stn - c0 =495 c1=high, c2 = 859, c3= high r stn - c8 = 537 c9 = high, c10 = 773, c11 = high.Previous to ins replacement on friday, the patient was programmed to: 0+ 1- and 11+ 10- and was getting therapy benefit.Currently, the clinician was attempting to reprogram patient but was either seeing "settings not available" / oor or patient was not getting a therapy benefit.The caller did have on combination that appeared to be ok when programming c10 @ 4.4ma but then patient started to droop his head.Caller reported the impedances do seem like they are changing.Patient had not been doing well since replacement on friday with return of symptoms.Suggested x-ray (close up imaging) to see if anything can be seen.Suggesting palpating with additional impedance testing.Caller will be reaching out to implanter to possibly perform exploratory surgery.Ins is right chest, lead and extension connections behind right ear.During original call, it was mentioned impedance issues were seen after the ins was replaced.Technical services (tss) interpreted this as after the activa was explanted and percept implanted but per follow-up note and email received, the initial percept in which impedance issues were first seen was replaced with another percept in an attempt to resolve the impedances, which was unsuccessful.The rep reports impedances didn't change via post op and the hcp texted rep monday and said they were unable to program above 1ma and rep was not at the appointment so rep is not sure if she tried programmed on the electrodes that were within range.She said she was going to order some x rays and go from there.Refer to manufacturer report 2182207-2022-00521 for related device.

Manufacturer Narrative

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

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.

Event Description

Additional information was received from the rep that the cause was not determined, some of the impedances got better at post op.Patient has therapy.Actions/interventions include that it was programmed around, a few impedances resolved.

• Brand Name: PERCEPT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13970976
• MDR Text Key: 290535618
• Report Number: 2182207-2022-00558
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000420987
• UDI-Public: 00763000420987
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2022
• Date Device Manufactured: 05/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 82 KG