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); Charging Problem (2892); Insufficient Information (3190); Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.It was reported that they have had a "heck of a time with the system all together".Pt further clarified since last friday when pt wants to check the program they "can't get there" and then pt stated when they do get there "after many tries" pt reported "it doesn't stay".Pt further clarified that they will set their therapy to pt's desired setting and stated they feel stimulation initially and then when pt gets up the next day pt reported "it's off again".Agent tried to clarify if pt is checking therapy and it's off or if pt is not feeling stimulation.Pt stated they are not feeling stimulation and stated when they check their therapy setting there are no numbers "assigned".Walked pt through checking therapy status on call and pt was initially getting device not responding.Pt stated this has been happening every time pt is trying to connect with ins.Patient services reviewed message meaning.Pt successfully connected with ins on call then reported getting por message and to check device battery level, therapy has been turned off.Pt stated following this pt got message that ins battery is low (below 0%).Patient services reviewed ins needs to be charged.Pt stated they have been trying to charge their ins for over a week now, but reported they have been "unable to get it done" (agent unclear why).Pt then stated they were seeing therapy on at 1.2 volts, but stated they didn't set it at that setting and reported "it's just doing it itself".Pt stated they had only turned therapy on when this occurred.Patient services reviewed again to charge pt's ins first.Provided education on how to charge ins and walked pt through charging.Pt successfully connected to charge ins with excellent connection, 10% battery level.Pt will continue charging ins fully.Patient services reviewed how to turn therapy on, check settings once pt is completed charging ins.Reviewed ps hours of operation.Agent did not ask about the circumstances that led to the reported issue.Pt will charge ins and then will connect with ins to ensure por message has cleared and pt's therapy is on at pt's desired setting.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12093845
• MDR Text Key: 259212622
• Report Number: 3004209178-2021-10188
• 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: P080025
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 06/30/2021
• Date Device Manufactured: 03/05/2020
• 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: 73 YR