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

Model Number ENTERRA II 37800

Device Problems Connection Problem (2900); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 06/07/2021

Event Type  Injury  

Event Description

My medtronic enterra ii 37800 gastric pacemaker system needed to be removed and a new system implanted because of a lead "failure" on(b)(6) 2021.The disruption in treatment caused relapse of symptoms w/ kept me out of work for almost a month.I want the system, which is was removed at (b)(6) hospital on (b)(6), evaluated for malfunction and/or defect.Frequency testing showed no connectivity of lead.Fda safety report id# (b)(4).

• Brand Name: GASTRIC PACEMAKER
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 12008119
• MDR Text Key: 256733657
• Report Number: MW5101909
• Device Sequence Number: 1
• Product Code: LNQ
• 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: 06/12/2021

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: No Information
• Device Expiration Date: 06/07/2021
• Device Model Number: ENTERRA II 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 44 YR
• Patient Weight: 104