MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number B35200

Device Problems High impedance (1291); Low impedance (2285); Application Program Problem (2880); Patient Device Interaction Problem (4001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

It was initially reported that a code 1703  was seen on patient therapy controller.During a telemed appointment the patient appeared more flexible than normal, and slumped.It was noted that the patient is wheelchair bound.  oor was discussed and tech specialist reviewed that caller should get the impedances checked.No falls or trauma were reported.Additional information was received from the rep reporting code 1703 on the patient communicator.The patient whips their upper body/ head and neck around and hits it against her wheel chair.The manufacturer representative met with the patient and checked impedances and at 1.0 ma, left side monopolar pairs are showing over 5k ohms and bipolars are over 10k ohms and right side all monopolars were low (8-60 ohms, 9-63 ohms, 10-63 ohms, 11-64 ohms) and bipolars 85-90 ohms.With patient being in a wheelchair, it's unknown if they may be hitting their head or leaning a certain way that may have caused an issue.They ran auto algorithm impedance and then left side, contact 0 (technical specialist was assuming monopolar) were showing 35k and rest were over 40k.Technical specialist reviewed component impedance measurements and that it appears for the right side, current is getting past adaptor and extension so issue may be on the lead.Imaging was recommended, but it was also reviewed that that it is likely a revision will be needed since there are no viable contacts.Rep asked about turning the implant off to conserve longevity and agent reviewed that is the healthcare provider's decision but at this point it's unlikely patient is getting any therapy so the implanted neurostimulator is likely not providing any stim and wouldn't need to be on.The representative was going to work with neurologist.

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, serial/lot# (b)(4), product type lead.Product id 3387s-40, serial/lot# v 091117, product type lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 02-jan-2011, udi#: (b)(4); product id: 3387s-40, serial/lot #: (b)(4), ubd: 02-jan-2011, udi#: (b)(4).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.It was reported, that the rep has not been informed of any surgeries.The battery has been shut off at this time.It was unknown, what the next steps are.The issue was not resolved at this time.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot#: v091117, product type: lead, product id: 3387s-40, lot#: v091117, product type: lead.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.

• Brand Name: PERCEPT
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13608433
• MDR Text Key: 296494657
• Report Number: 3004209178-2022-02545
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00763000420987
• UDI-Public: 00763000420987
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Date Device Manufactured: 12/02/2020
• 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: 25 YR
• Patient Sex: Female