MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number 37612

Device Problems Display or Visual Feedback Problem (1184); Charging Problem (2892); Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37761, serial# (b)(6).Product type: recharger.Section d information references the main component of the system.Other relevant device(s) are: product id: 37761, serial/lot #: (b)(6).H3: analysis of the 37761 desktop charger (dtc) (s/n (b)(6)) revealed bent connector pin.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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 desktop charger (dtc) connection when plugged into the recharger was loose, and the recharger only charges when the cord was held in certain positions.The patient mentioned they previously received a replacement dtc for the same reason, and that when asked event date, the patient did not know, stating the replacement dtc worked 2 times and then the issue happened again.Patient stated the port of the recharger had no visible damage and did not mention visible dtc damage.During the call, the patient noticed the antenna connection to the recharger seemed to not be as tight as it was previously.During the call, the patient mentioned a recharger screen but agent could not confirm what the patient was describing.When agent asked for the serial number, patient stated seeing something they had never seen before, and described seeing a list of numbers or characters "across the bottom wind ow." additional information was received from the patient that the replacement recharger sent out did not resolve the issue.During the call, patient rep mentioned the patient has dementia and may have difficulty returning the replaced items.Pss thoroughly reviewed which devices would need to be sent back to mdt and what the patient needed to keep.Patient rep asked if someone would be able to come out to assist the patient if needed.Pss reviewed role of rep.Additional information was received from the consumer who reported the patient was charging their ins during the call and stated prior to their system running down a week or two ago, they could see the fully charged, charge complete screen.They reported that the newest equipment was working but they have not yet seen the charge complete screen.The patient said prior to this they had been recharging every other week and it was nearly empty every other week and it was quite a long process.The patient reported when they repositioned the recharger antenna they saw 6 or 8 black coup ling boxes during the call.Reviewed some recharging information and best practices.Confirmed their equipment was working as expected.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 18867499
• MDR Text Key: 337588256
• Report Number: 3004209178-2024-06639
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2012
• 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 H11...."
• Patient Sex: Male