MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT

Model Number B35200

Device Problems Pocket Stimulation (1463); Patient Device Interaction Problem (4001)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 05/20/2021

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 reported a "funny feeling" over their implanted neurostimulator (ins) in the chest 250 times a day that started about 3 weeks after replacement.The feeling is electrical in nature and somewhat vibrational but not shocking nor painful.Caller indicated that if patient raises their arm above their head, the sensation immediately goes away and returns if patient puts their arm down.Patient was seen in office last week and caller tested impedances which were all normal and patient hasn't reported any therapy issues.Caller stated they tested impedances in various positions including patient turning their head different ways and raising their arm above their head (so sensation was not present) but impedances remained normal and no issues were seen.While interrogating ins and running initial impedances, patient's arm was at their side and they could feel the sensation but there wasn't anything seen upon interrogation that would explain the sensation or indicate a problem with the system.Caller mentioned that patient is a carpenter/woodworker and does electrical work but they are currently not working.Caller examined ins site and saw nothing of concern.Caller stated they did not change anything with dbs at the appointment nor did they order imaging or take any further action since patient is receiving effective therapy.Caller speculated issue may be mechanical in nature with percept being smaller in the same pocket than previous pc.The caller was not with the patient.The caller was redirected to consider turning the ins off to see whether sensation ceases.Caller discussed they will likely bring patient back into office to palpate system, turn ins and monitor the issue.

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 received from the healthcare provider (hcp) reported the issue has continued to the patient was going to be coming into the office today and wanted to discuss options.Impedance had been checked in multiple times in multiple positions (including when left arm was up-when was when the issue resolved-and when the left warm was down) and impedance are normal.(the implantable neurostimulator (ins) is on the left side).The hcp had not tried turning the ins off due to the patient¿s condition and the patient lives alone, but may try that along with imaging.It was reviewed the current ins was bigger than the last and the physical pocket could be prompting this.

• Brand Name: PERCEPT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12108300
• MDR Text Key: 259666112
• Report Number: 3004209178-2021-10324
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000420987
• UDI-Public: 00763000420987
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR