MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 97810

Device Problems Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 06/20/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient indicates that when they were trying to recharge yesterday that they saw a screen showing 2 4 12 and flashing red battery and they also had a por yesterday.The patient indicated that their device had been turned off and that their bladder was terrible for days.The patient indicated that when they finally connected to the device, the battery was at 60%.The patient was able to resolve the screen and charge to 100%.The patient wants to know what turned their device off and inquired about the code.The patient indicated no recent medical test/procedures.Reviewed open loop screen and por.Reviewed that battery had likely been depleted.The patient questioned that because they saw 60% on the screen.Reviewed that the recharger can charge the ins independent of the app.Patient indicated that they were charging once per week, advised the patient to check the battery level more frequently and how to do that.The patient asked if there was a way to look at the device to see what happened exactly.The patient was redirected to their healthcare provider to further address the issue.No further complications were reported at this time.

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: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 14961800
• MDR Text Key: 300675784
• Report Number: 3004209178-2022-08670
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2022

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: 11/14/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/08/2022
• Date Device Manufactured: 05/15/2021
• 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: 42 YR
• Patient Sex: Female