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

Model Number 37601

Device Problems Failure to Deliver Energy (1211); Loss of Data (2903)

Patient Problems Muscular Rigidity (1968); Seizures (2063); Therapeutic Response, Decreased (2271); Cognitive Changes (2551); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) who reported after a patient was initially programmed by a tablet and then programmed with a clinician programmer the settings were lost.Over the weekend, they required an emergency room (er) visit due to being completely frozen from a loss of therapy and body available to reprogram them so they were sent home.The patient followed up with their hcp on monday, but it was unclear what was exactly done.Later on monday the patient was convulsing and admitted, but they didn't know the ¿nuances¿ of what actually occurred.The consumer¿s main reason for contacting the manufacturer was due to lack of communication in loss of settings if a clinician programmer was used after programming with a tablet.The consumer stated there should be a ¿huge campaign¿ to educate hcp¿s, especially those who don't program very often and are typically comfortable using the clinician programmer.The consumer stated they were never notified of this potential issue if there was information sent out and the reps didn't seem to know it was a problem either.The consumer noted the hcp who programmed the patient with a clinician programmer didn't have a tablet as the other hcp in their practice left and took the tablet with them.The consumer noted they perform implants and typically see patients at their 3 and 6 month follow-up but some of their patients leave for times of the year and see other hcp¿s which concerned them.The consumer noted they keep their clinician programmer due to the occasional patient coming with an older device, but they were going to label the clinician programmer to only be used with these types of patients going forward.According to the hcp the settings being lost happened with another patient as well.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported they met with the patient on december 1st and did a slight increase in stimulation for the right and left (.1 ma both sides).The patient was also taken off a new medication and was doing better.

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.

Manufacturer Narrative

H6.The codes have been updated to reflect the most current coding.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 healthcare provider (hcp) reporting they believe the patient was manually reprogrammed.Also, the timeframe is unknown, but after having been discharged over the weekend when they lost their settings, the patient tested positive for covid.The patient¿s wife believes the local neurologist fried the patient¿s brain and that everything going on currently with the patient is due to the lost settings.The healthcare provider (hcp) believes due to the loss of settings, it is not running a surge through the system and patient has decline of cognition.The patient has not recovered.A manufacturer representative (rep) is seeing the patient on tuesday to make sure the patient is on current/correct settings and to rule out settings are causing the symptoms.The healthcare provider (hcp) stated the settings were previously changed due to dystonia.The manufacturer representative (rep) has provided the physician a tablet and training.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 8840 serial# unknown product type programmer, physician.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: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN 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: 10793596
• MDR Text Key: 215036492
• Report Number: 3004209178-2020-19397
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Date Device Manufactured: 06/17/2015
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 88 KG