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

Model Number B35200

Device Problems High impedance (1291); Energy Output Problem (1431); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Ambulation Difficulties (2544)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

The event date is an estimated date.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient saw 1703 error on the handset.The patient was trying to sync the handset to make stim changes but saw the error code.The patient has fallen a few times in the last week.They fell a few days ago and again on dec-27.For a few days, the handset has been showing "out of range" code 1703 and the patient is unable to increase settings.When settings are increased, the handset has been showing code 1098.They reported that an error code came up on the handset stating "not found, communicator".They reported the communicator was off.They powered it back on and confirmed it connected to the handset.However, they saw 'out of range.Contact your clinician.The neurostimulator is providing less than the requested therapy.Service code 1703' error message.They pressed continue and saw the therapy screen, noting the implantable neurostimulator (ins) battery level is ok and therapy is on.They are trying to increase the amplitude from 3.4 to 3.6 but when they try to increase, they get the same 'out of range' error message except with a 1098 service code.It was reviewed that the error messages are appearing due to a limitation of the current ins programming.They mentioned that the patient's neurologist increased the amplitude to 3.6 about 2 weeks ago but the amplitude is currently at 3.4 and won't go higher.They were directed to the patient's healthcare provider (hcp) to assist.Additional information was received from a healthcare provider (hcp) via a manufacturer representative (rep) clarifying that when they interrogated the device last tuesday, the patient had high impedances (>10k ohms) at their therapeutic contact (10-) in the right globus pallidus (gpi) lead.The physician switched the patient's therapeutic contact to the most distal contact (11-), and the patient immediately started feeling some mild benefits, specifically improved voice.They got an x-ray of the patient's deep brain stimulation (dbs) leads and there were no interruptions in the leads.The patient does fall frequently but the physician does think the patient's motor benefit worsened when the right gpi dbs was not working due to high impedances at that contact, so the patient could have been falling more frequently in light of their interrupted stimulation.The physician is not sure what error code the patient has been seeing, now that they switched contacts and unknown if the service errors resolved.They instructed the patient to increase their amplitudes slowly at home to see how they feel.

• Brand Name: PERCEPT
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11218786
• MDR Text Key: 228468552
• Report Number: 3004209178-2021-01245
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000253363
• UDI-Public: 00763000253363
• 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
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2020
• Date Device Manufactured: 03/23/2020
• 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: 64 YR