MAUDE Adverse Event Report: ENDOSTIM, INC. ENDOSTIM; IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX

Model Number STIMULATOR: 1006

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2018

Event Type  malfunction  

Event Description

Broken lead from the endostim generator (irb study).Patient wished to have it removed rather than replaced.

• Brand Name: ENDOSTIM
• Type of Device: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
• Manufacturer (Section D): ENDOSTIM, INC.; 1609 shoal creek blvd.; suite 303; austin TX 78701
• MDR Report Key: 8124157
• MDR Text Key: 129058932
• Report Number: 8124157
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: STIMULATOR: 1006
• Device Lot Number: 3338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1