MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37602

Device Problems Disconnection (1171); High impedance (1291); Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3389-40; lot#: j0211638v; implanted: (b)(6) 2002; product type: lead.Product id: 37602; serial#: (b)(4); product type: implantable neurostimulator.Product id: neu_unknown_ext; serial#: unknown; product type: extension.Other relevant device(s) are: product id: 3389-40, serial/lot #: (b)(4), ubd: 16-apr-2006, udi#: (b)(4); product id: neu_unknown_ext, serial/lot #: unknown, ubd: 16-apr-2006.If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6) 2021.Rtg0237766 (rep): it was reported that the impedances are out of range.The unipolar impedances are all >5000ohms and the bipolar impedances are between 995 - 3536 ohms.Technical services (ts) reviewed that it is most likely that the extension came out of the ins socket.The provider replaced the implanted device and the impedances remained the same.During investigation, additional information received from the manufacturer¿s representative (rep) reported they reviewed previous impedances and dating back to 2020 impedances had been out of range.The patient mentioned they felt things may have been ¿off¿ since the beginning.The rep mentioned the patient was symptomatic (rigid and stiff) so it was unknown if they had been getting therapy or not.Images and impedance testing was reviewed which appeared the lead became disconnected from the extension therefore it was likely fluid/tissue had ingressed into the distal end of the extension causing the expected impedance measurements so that the monopolar path gave a reading as op posed to just over 40,000 ohms (but this wasn¿t confirmed).It was reviewed that while the bipolar measurements are ¿in range¿ they were still suspect given the imaging and what was occurring with monopolar pairs.It was unknown what was going to happen next as they were waiting for neurologist/neurosurgeon for further steps.Refer to manufacturer report #2182207-2021-02176 for details pertaining to the related reportable event.

Manufacturer Narrative

Concomitant medical products: product id: 3389-40; lot#: j0211638v; implanted: (b)(6) 2002; product type: lead.Product id: 37602; serial#: (b)(4); product type: implantable neurostimulator.Product id: neu_unknown_ext; serial#: unknown; product type: extension.Other relevant device(s) are: product id: 3389-40, serial/lot #: (b)(4), ubd: 16-apr-2006, udi#: (b)(4); product id: neu_unknown_ext, serial/lot #: unknown, ubd: 16-apr-2006.If information is provided in the future, a supplemental report will be issued.

Event Description

2021-nov-15 (b)(4): it was reported that the impedances are out of range.The unipolar impedances are all >5000ohms and the bipolar impedances are between 995 - 3536 ohms.Technical services (ts) reviewed that it is most likely that the extension came out of the ins socket.The provider replaced the implanted device and the impedances remained the same.During investigation, additional information received from the manufacturer¿s representative (rep) reported they reviewed previous impedances and dating back to 2020 impedances had been out of range.The patient mentioned they felt things may have been ¿off¿ since the beginning.The rep mentioned the patient was symptomatic (rigid and stiff) so it was unknown if they had been getting therapy or not.Images and impedance testing was reviewed which appeared the lead became disconnected from the extension therefore it was likely fluid/tissue had ingressed into the distal end of the extension causing the expected impedance measurements so that the monopolar path gave a reading as op posed to just over 40,000 ohms (but this wasn¿t confirmed).It was reviewed that while the bipolar measurements are ¿in range¿ they were still suspect given the imaging and what was occurring with monopolar pairs.It was unknown what was going to happen next as they were waiting for neurologist/neurosurgeon for further steps.Refer to manufacturer report #2182207-2021-02176 for details pertaining to the related reportable event.

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 (rep) reporting that the event has not been resolved.They are scheduling extension replacement for january.

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 impedances resolve during the lead revision, however the target was incorrect so no stimulation could be provided to side effects at low ma.

• Brand Name: ACTIVA
• 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: 13005859
• MDR Text Key: 286123368
• Report Number: 3004209178-2021-18529
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864207
• UDI-Public: 00643169864207
• 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,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2022
• Date Device Manufactured: 05/20/2019
• 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 Sex: Male