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

Model Number 37612

Device Problems Failure to Interrogate (1332); Unstable (1667); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)

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

Event Date 01/15/2023

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are:product id: wr9200, lot#: serial#: (b)(4), implanted:, 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.

Event Description

Information was received from a patient's representative regarding an external device.The reason for call was the wireless recharger (wr) was not maintaining a good connection with the implantable neurostimulator (ins).The caller noted that the wr kept beeping continuously as it searched for the ins, and they could only get it to make a connection for no more than 30 seconds before it started beeping again.Before calling patient services, the caller said they repositioned the wr several times and ensured the wr was positioned directly over the ins.The caller mentioned that as they were palpating the ins they noticed the ins seemed like it moved a little bit.The caller tried placing the wr directly over the ins without using the drape, but it made no difference.The caller also said they reset the wr by holding down the power button for 45 seconds, but that didn't make a difference either.The caller mentioned that the tm90 communicator was able to connect to the ins without an issue.During the call, the wr made a connection to the ins within a few seconds, but after a few seconds it lost the connection and the wr began to beep continuously.The wr would intermittently make a connection, but the connection would be lost within seconds.The caller was not using the drape, so they had the wr directly against the ins as the patient was lying down on their back.The caller confirmed the wr was in the correct position.Agent had the caller reset the wr, but the issue persisted.The caller mentioned that they had called manufacturer representative (rep)  about this issue, but the rep could not resolve the issue either and redirected the caller to patient services.The issue was not resolved.An email was sent to the repair department to replace the wr.No symptoms reported.Additional information received from the consumer reported they received the replacement recharger, but it was doing the same thing where the recharger found the implant, but then disconnected and kept beeping and showing a 1713 code.Later that day the manufacturer¿s representative (rep) met with the consumer and the wireless recharger wouldn¿t charge the implant and neither did the original.It was confirmed the tablet and patient controller were able to connect with the implant.During the call it was identified the implant was flipped so the rep flipped the implant and was now able to charge.

Event Description

Additional information received from the consumer reported they believed that due to the location of the implant being under the collar bone on the right side, when the patient sleeps, they are an active mover and act out in their dreams, so that could have caused the flip.

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: 16224607
• MDR Text Key: 309088070
• Report Number: 3004209178-2023-00940
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000519247
• UDI-Public: 00763000519247
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2023
• Date Device Manufactured: 06/16/2022
• 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 Age: 79 YR
• Patient Sex: Male