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

Model Number 37612

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Charging Problem (2892)

Patient Problems Fall (1848); Pain (1994); Shaking/Tremors (2515); Unspecified Tissue Injury (4559)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id 37751, serial# (b)(6), 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

Patient services (pss) received call from patient stating that they have been promised on how the new equipment is works, but no one has helped them or showed them how to use it.The caller stated that they previously called ps and the replacement equipment they received did not resolve the issue.The caller stated that they first fell about five weeks / two months ago and has fallen many times and has been injured due to the falls, the caller stated they have fallen many times since asking for new equipment.The caller stated that the wires are all frayed.The caller stated that the wires are both frayed.The caller stated that when they went to the healthcare provider (hcp) the hcp had to reprogram the patients implantable neurostimulator (ins) and it was very painful , and that it had to be redone.Pss suggested that when resuming therapy to have stimulation at a low setting.The caller also stated that their hands still shakes. pss sent an email to repair replace the 37751 recharger due to the patient being escalated and needing to charge.Pss also redirected the patient to hcp in providing further assistance.Additional information received from the consumer reported they got a wireless recharger a few weeks ago in exchange for a legacy recharger.However, it was ¿impossible for them to use the wireless recharger due to its¿ size with the location of the implant.¿ right away they noticed the implant was implanted up high and too close to their neck which made it very difficulty for them to get the wireless recharger in the proper position.Due to this they decided not to use the wireless recharger due to the difficulties they experienced with it and the rep saying ¿that thing is going to cause problems.¿ the rep took the legacy recharger, but they wanted it back because it worked better for them.The rep was going to contact the patient.Unrelated ins lasted over a year event captured in pe 705747552.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported they were going to see the patient on (b)(6) to assist with recharging on the new recharger and utilizing the adhesive discs to see if it helped keep the recharger in place.The patient was also going to be sent a replacement power supply for their existing system which was the only piece that wasn¿t working.

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 ESSENTI
• 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: 18442540
• MDR Text Key: 331863468
• Report Number: 3004209178-2024-00178
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2024
• Date Device Manufactured: 01/22/2019
• 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
• Treatment: SEE H10
• Patient Age: 82 YR
• Patient Sex: Female