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

Model Number 37602

Device Problems High impedance (1291); Migration or Expulsion of Device (1395)

Patient Problem Shaking/Tremors (2515)

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 748240, serial/lot #: (b)(4), ubd: 03-feb-2009, udi#: (b)(4) ; product id: 748240, serial/lot #: (b)(4), ubd: 03-apr-2007, udi#: (b)(4) ; product id: 3389-40, serial/lot #: (b)(4), ubd: 16-dec-2008, udi#: (b)(4) ; product id: 3389-40, serial/lot #: (b)(4), ubd: 16-dec-2008, 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

It was reported that the patient met with the healthcare provider (hcp) in (b)(6) and impedance was normal at the time, but when the hcp checked impedance on (b)(6) , the impedance was high at around 6000 ohms.The manufacturer representative (rep) reported that the patient had tremor symptoms.The rep said the hcp inquired why the vna was different when looking at current mode compared to voltage mode.Technical services(ts) told rep that if impedance was considered when calculating the equivalent amplitude, then vna should be similar when in current or voltage mode.The rep did mention that the hcp can only increase up to 0.4 ma at one point, but in another instance, the hcp was able to increase to 2.6 ma.Ts told the rep that it's possible that there might be fluctuations in the impedance, which resulted in hcp's ability to increase stimulation only to 0.4 ma and then later at 2.6 ma - fluctuations in the vna could be the result of impedance changes.The caller was not with the patient.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the rep that the patient was scheduled to have surgery to determine the cause of the high impedance and replace the extensions if necessary.The surgery was scheduled for (b)(6) 2022.The information was confirmed with the hcp.The patient was taken into surgery today, (b)(6) 2022.They didn't see anything at the ins/extension area but noted that the lead/extension connection had migrated down the neck.The old extension and ins were removed and replaced.The rep stated they were still seeing a high impedance of 6000 - 8000 ohms today.It is known at some point the lead will need to be replaced but the patient is managing fine now.Refer to manufacturer report 3004209178-2022-12579 for related device.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the patient was requested the left lead be replaced, but the managing neurologist and neurosurgeon were still discussing this as an option and thus no surgery had been scheduled.The devices that were removed were discarded and would not be sent back for analysis.

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.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 15563800
• MDR Text Key: 301364812
• Report Number: 3004209178-2022-13057
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000519223
• UDI-Public: 00763000519223
• 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
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 11/08/2022
• Date Device Manufactured: 03/29/2022
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female