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

Model Number 37612

Device Problems Migration or Expulsion of Device (1395); Overheating of Device (1437); Unstable (1667); Malposition of Device (2616); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Burning Sensation (2146); Discomfort (2330)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: wr9200, serial#: (b)(4), product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via manufacturing representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient was experiencing discomfort/heat when recharging and heard a clicking sound.The patient was still healing from surgery and he may be sensitive to the heat.No symptoms were reported.Additional information was received that the heating is from the recharger.Cause of heating is undetermined.Actions taken was having patient turn recharging down to lowest level to reduce heating and waited a further 2 weeks for healing.Patient charges battery with a shirt on now instead of directly on skin.The heating is only an issue if the patient does not have a shirt barrier.Additional information was received from a manufacturer representative (rep) reporting the patient is still experiencing heating while recharging.They are using the lowest speed and the patient is wearing a sweatshirt during the recharging period.The patient is recharging for hours due to the lowest speed.The rep did not inquire about wound healing.It was discussed checking the pocket and asking the patient to charge more frequently for less time if possible until the wound fully heals.The patient's girlfriend also believes the recharger is heating up more than normal as well.It was discussed checking the wireless recharger (wr) by trying to recharge an ins in the box or patient's ins and actual temperature of the wr.Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the patient thought their surgical site looked normal, however, the surgeon was going to see the patient in clinic for further assessment.The cause of the heating had not been determined yet, but the patient¿s physician was going to check the incision site to rule out infection and the rep was going to troubleshoot at that time.However, in the meantime the patient was told to charge their battery more frequently so they weren¿t charging for 2-3 hours at a time to reduce heating.

Event Description

Additional information was received that the patient does not have an infection.The patient reducing charging time has resolved the heating sensation.

Manufacturer Narrative

Continuation of d10: product id wr9200, serial# (b)(6), explanted: product type recharger.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 patient was still experiencing heating while recharging.The healthcare provider (hcp) checked for infection but found no infection.The rep stated the implantable neurostimulator (ins) felt tilted in the pocket so the hcp was going to do a pocket revision and replace the ins.

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: codes have been updated to reflect the new information.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

Added h4 (mfg date) h3 other text : additional information.

Event Description

Additional information was received from a manufacturer representative (rep) reporting the physician determined that the battery was tilted to be the cause of heating.Also, the patient had accidentally increased their charging speed which increased heating.It was determined that the ins was only charging up to 25% because of heating and not because of an ins charging issue.They lowered the patient's charging speed to 1 and the issues were resolved.

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.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
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11177341
• MDR Text Key: 227029340
• Report Number: 3004209178-2021-00848
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 00763000100360
• UDI-Public: 00763000100360
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/12/2021

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: 07/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/29/2021; 01/27/2021; 03/09/2021; 03/29/2021; 04/07/2021
• Supplement Dates FDA Received: 01/29/2021; 02/01/2021; 03/15/2021; 04/02/2021; 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 26 YR