MAUDE Adverse Event Report: MEDTRONIC ENTERRA THREAPY; ENTERRA

Device Problems Material Erosion (1214); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 08/17/2017

Event Type  Injury  

Event Description

(b)(6) 2012: initial implant (device info not available.) (b)(6) 2017: revision due to dysfunction of device (b)(4).(b)(6) 2017: revision due to lead erosion; device generator (b)(4), lead (b)(4).

• Brand Name: ENTERRA THREAPY
• Type of Device: ENTERRA
• Manufacturer (Section D): MEDTRONIC; 7000 central ave ne; rce250; minneapolils MN 55432 3576
• MDR Report Key: 7066834
• MDR Text Key: 93353981
• Report Number: MW5073613
• Device Sequence Number: 2
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/13/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR
• Patient Weight: 56