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

Model Number 37612

Device Problems Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009)

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

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient indicated not being about to stay coupled with ins, after connecting wr to ins about 10-15 seconds later starts beeping to find ins, the recharger app code is 2702.The reason for call was too see what code 2702 is.Patient services (pss) reviewed 2702 is poor coupling / communication.Patient is traveling in (b)(6) and caller inquired if we can send a replacement.Caller indicted patient will be contacting pss.  patient indicated recharging has been getting worse the past few weeks, and past few days has been difficult.No symptoms were reported.Additional information was received.It was reported that the cause of the coupling issue/error 2702 was not determined.After the rep reviewed best practices for good coupling, the patient was referred to patient services for a replacement recharger.The rep called the patient back to see if they were still experiencing problems and the patient said they were not and they were able to fully charge that day without incident.The issue was resolved at this time.Additional information was received.Information regarding issues with poor coupling and the 2702 error code was reported.The patient noted that they get the 2702 error code probably 80% of the time they use the wr.The patient confirmed that the 2702 message was a 'recharger error' that asked them to reset the wr by pressing and holding down the power button for 20-30 seconds.The patient confirmed that they reset the wr, but the 2702 error would resurface.Regarding the poor coupling, the patient thought it may have been the way the ins was implanted, because for a time they noticed they could get better coupling if they held the wr firm against their chest.The patient mentioned that they tried to improve coupling by taking the wr out of the drape, putting the wr in their bra, and holding the wr tight up against their ins, but they still hardly ever got an 'excellent' connection.Due to the persistent 2702 error code, an email was sent to the repair department to replace the wr.

Event Description

Additional information was received from the consumer who reported that they think they replacement recharger resolved the coupling issue and they only used it once so far.They stated that the problem is the weight and size of the charger, that they can't do anything but charge- "very restricting".They can't locate the "sweet spot".

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: 14141935
• MDR Text Key: 289528261
• Report Number: 3004209178-2022-04945
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2022
• Date Device Manufactured: 01/22/2021
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Weight: 82 KG