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

Model Number B35200

Device Problems Break (1069); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Impedance Problem (2950)

Patient Problems Electric Shock (2554); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  Injury  

Event Description

It was reported by the manufacturer representative (rep) that an impedance issue was found on 2023 (b)(6) while the patient was in an ekg.The rep ran an impedance check of the system and saw an issue on the left brain lead.When they palpated along the lead and extension, this made the impedances worse.The right side ins showed normal impedances since (b)(6) 2023 (implant date).There was no report of any therapy changes or issues per the rep.It was discussed that ins was showing eri (eight months).The caller was looking to see about running longevity calculation with load and non-load to know if it is better to keep the same ins or consider implanting a new one.Further discussion with hcp will be had.There is no timeframe set yet for a revision of the extension.The caller did not know when the left lead (left brain) changes began or any activities that may have been attributed to it.2023 (b)(6) e1, e2 (rep): additional information received from the manufacturer¿s representative (rep) reported monopolar impedances for left were all out of range: 0-3593, 1-2984, 2-3677, 3-3647, all bipolar were within normal range, from 2669-3578.The rep noted the device did not reach eri under normal circumstances as there was no eri message, with the longevity of the device battery being eight months based on the last seven days of programmed settings.The impedance issue was not resolved because when the physician went in to explore the lead/extension connection on (b)(6) 2023, they noticed the lead above the extension connection was ¿frayed, and the lead was fractured but chose not to explant any components at this time.They believed the fracture happened when a few months prior a physical therapist showed the patient a neck exercise which extended their neck significantly.Shortly after, the patient started getting intermittent ¿shocks¿ that were minimal and sporadic that overtime became more significant and frequent.The patient would see how they do with the one right intact system with their symptoms but may elect to get a new left lead and extension at some point.

Manufacturer Narrative

Continuation of d10: product id: 3387s-40, lot#: va2bjug.Implanted: 2021 (b)(6), product type: lead.Product id: 3708660, serial#: (b)(6), implanted: 2021 (b)(6), product type: extension.Section d information references the main component of the system.Other relevant device(s) are: ubd: 12-aug-2023, udi#: (b)(4) ; ubd: 01-apr-2024, 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.

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 manufacturer¿s representative (rep),which was confirmed with the healthcare provider (hcp), they decided not to explant the components during the surgery as it would have been more invasive, and they didn¿t want to make any other incisions.The decreased longevity estimate of 8 months was a result of the inaccurate high impedances because of the potential intermittent fracture.The patient¿s shocks had resolved since the left lead extension was not active at this time.

• Brand Name: PERCEPT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 18070474
• MDR Text Key: 327355930
• Report Number: 3004209178-2023-19055
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000642174
• UDI-Public: 00763000642174
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2023
• Date Device Manufactured: 03/01/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male