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

Model Number B35200

Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

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

It was reported that the manufacturer representative (rep) met with the patient in the doctor's office to do routine therapy adjustment.They were unable to connect/communicate to the implantable neurostimulator (ins) with their tablet and communicator and the doctor's tablet/communicator.The patient's handset and communicator worked fine (tel-m).The rep did mention that the patient had a fall "2 weeks ago from last friday." the patient sustained an injury on their face, left knee and broke their nose from the fall.The patient did not fall on the ins.In follow up, it was clarified that the fall was not related to the device/therapy and that they were in a parking lot and tripped.Additional information was received on 2022-feb-24 from a manufacturer representative (rep) reporting that the patient was not able to turn their therapy off with their patient handset.During troubleshooting, the rep used a different clinician tablet and powered everything down to see if it would reset on the clinician tablet.The tablet would communicate to the communicator but would not connect to the ins/kept searching for the ins even with the communicator held right against the ins as well as off since it was the percept.

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.

Event Description

Additional information received from a rep indicated that at a follow-up meeting on 7 april the rep interrogated the patient¿s percept pc ins using the a610 clinician therapy application and was unable to establish communication.A reset of the patient¿s ins was then performed using the tel-m ins reset tool.Afterwards the a610 and a620 were able to establish telemetry with the patient¿s percept pc ins, and the patient's stimulation settings were confirmed.

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) reported the handset/communicator was able to connect to the implant, but wouldn¿t turn it off.

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) reported after the reset the implant worked fine as the patient had been seen every 6 months and had been able to interrogate without any issue.Last thursday the healthcare provider (hcp) attempted to interrogate the device with their tablet, but was unable to connect, and the rep was unable to connect with their tablet either.It was noted the patient had a fall last month and broke some ribs on their left side, but the implant was on the right side; nothing else unusual had occurred.It was noted the handset was able to connect, but the patient couldn¿t increase their stimulation as they were maxed out on their intensity limits, but they needed more intensity to control their tremor (unrelated to the device/therapy, progression of the disease).It was confirmed both tablets were up to date.The rep then mentioned the patient couldn¿t turn therapy off with their handset.

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 was received from a manufacturer representative.It was reported that an engineering individual met with this patient on (b)(6) 2023.The rep was able to successfully connect to the ins.Logs and reports were gathered.The patient's ins was able to be reset using the ins reset command.After the reset, the software applications were able to successfully communicate with the patient's ins, and the patient's stimulation settings were confirmed.

Event Description

Additional information was received from the healthcare provider (hcp) stating that they were not able to interrogate their implantable pulse generator (ipg).The hcp tried with 2 clinician tablets with no success.The hcp was able to use the patient programmer to interrogate the ipg but could not turn off therapy.The hcp is meeting with an engineer from the manufacturer on 2023-03-02 at the doctor's office to try and reset the patient's ipg.There are no external/environmental/patient factors that may be contributing to this issue.The issue was not resolved at the time of this report.No symptoms were reported.

Manufacturer Narrative

This regulatory report is being submitted as a correction as it was determined that there was 2 duplicate events.Please note that r egulatory event #3004209178-2023-03375 is now obsolete and any future information will be submitted into regulatory event #3004209178-2022-03412.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that patient (pt) came into clinic for programming adjustments and when manufacturer representative (rep) went to in terrogate the implantable neurostimulator (ins) with the clinician programmer, it would not connect.Rep tried 2 different tablets and communicators and neither one worked.Rep also tried to use her patient programmer and it would connect but rep wasn't able to turn off therapy with the patient programmer.This has previously occurred to this patient and an engineer had to come and reset the ins.Rep believed patient was encountering the 'dbs percept pc unable to be interrogated (fa1231)' issue for the second time. rep called and reported this to tech services (tss)  and they are escalating it to see if an engineer needs to come out again to reset it.Tss sent request to engineering to f/u with rep for next steps regarding possible tel-n lock up.No symptoms reported.Additional information was received: it was reported that the engineer was able to reset the ipg.The rep connected to the ipg, made changes with the clinician programmer, and was able to turn off the ipg with the patient programmer as well.This case has been resolved on april 18, 2024.

• Brand Name: PERCEPT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTIAL 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13801287
• MDR Text Key: 297242095
• Report Number: 3004209178-2022-03412
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2023
• Date Device Manufactured: 05/21/2020
• 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: 88 YR
• Patient Sex: Female
• Patient Weight: 64 KG