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

Model Number B35200

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); High impedance (1291); Failure to Interrogate (1332); Communication or Transmission Problem (2896)

Patient Problems Shaking/Tremors (2515); Insufficient Information (4580)

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown.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

It was reported that the patient (pt) was seen today for loss of therapy benefit.Impedances were ran and electrodes 1, 2 & 3 were reported to be out of range.The patient had an x-ray and the managing healthcare provider (hcp) would like the extension replaced.The pt reported the loss of therapy sometime in may and occurred right after a mammogram.Unknown date of revision and is not scheduled at this time.

Manufacturer Narrative

Continuation of d10: product id 3708660 lot# serial# (b)(6) implanted: explanted: product type extension 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 that upon further discussion with the hcp, the extension is not going to be replaced at this time.The hcp is using the 0 contact to provide therapy.The patient is agreeable to this for now.It is believed that the mammogram did effect the extension in some way, exactly how it was effected is undetermined.

Event Description

It was reported that patient was having issues connecting to her ins with handset and communicator.Hcp requested a manufacturer representative (rep) be present when bringing patient into office on wednesday.Hcp indicated per patent, it keeps trying to connect to ins and timeouts.Patient has been recently read by tablet successfully so there doesn't appear to be an issue with the ins.Caller indicated the patient has been having the issue for a few weeks, but then mentioned has been awhile.Additional information was received that the patient had a left side therapy issue.Patient was attempting to check ins due to this issue, but was unable to connect to ins.Patient was seen by hcp last week.Additional information was received from the consumer who reported that the left side was not connecting and "consult with clinician".It was stated that the circumstances that led to the connection issue was after a mammogram, the patient's left side shook out of control.On (b)(6) 2022 the patient had a visit with the hcp and the connection issue was not resolved.The patient had an appointment on (b)(6) 2022 with the hcp for the left side therapy issue and the hcp gave the patient partial service on the left side and had an appointment on (b)(6) 2022.

Manufacturer Narrative

Concomitant medical product: product id 3708660, serial# (b)(6) product type extension 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.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: 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: 14878715
• MDR Text Key: 303165065
• Report Number: 3004209178-2022-08338
• Device Sequence Number: 1
• Product Code: PJS
• 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,Followup,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/02/2022; 06/27/2022
• Supplement Dates FDA Received: 07/06/2022; 07/25/2022
• Date Device Manufactured: 03/10/2020
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 59 KG