MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC GASTRIC ELECTRICAL STIMULATOR; INTESTINAL STIMULATOR

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 01/15/2018

Event Type  Injury  

Event Description

Required a follow-on surgery; i had a medtronic gastric electric stimulator implanted in my abdomen (b)(6) 2018.Within a couple days of recovery i began experiencing electric shocks.My dr's claimed they had never seen this side effect and that it was nearly impossible.We turned the stim off then they did blind adjustments to my stim not telling me if it was on or off.I was required to keep notes on my symptoms and this showed them that it was not "in my head".I experienced shocks from movement and when eating food.The pain of the shocks was so significant at one point that i could not move, my daughter was able to help me to the couch.When i sat down i passed out from the pain.Another time an ambulance was called however, the only place that could turn my stim off was over 40 minutes away.We tried to work through this "anomaly" until they were able to schedule an omentoplasty to wrap my stomach with my omentum as a form of "insulation".Multiple calls from my gi dr, myself and my surgeon to medtronic (manufacturer) were not helpful.Medtronic claimed that this had not happened before.A later call to medtronic they stated it happens "sometimes".Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC GASTRIC ELECTRICAL STIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 10074420
• MDR Text Key: 191613947
• Report Number: MW5094551
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ADDERALL; ALPRAZOLAM; AMT PEG/J FEEDING TUBE; POWERPORT; ZYRTEC
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 49