MAUDE Adverse Event Report: MEDTRONIC INTERRA THERAPY; INTERRA

Device Problem High impedance (1291)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 12/29/2016

Event Type  Injury  

Event Description

Device explanted due to malfunction (high impedance).(b)(6) 2016: initial implant generator (b)(4), lead (b)(4).On (b)(6) 2016: device explant due to device dysfunction (high impedance.).

• Brand Name: INTERRA THERAPY
• Type of Device: INTERRA
• Manufacturer (Section D): MEDTRONIC; 7000 central ave ne; rce250; minneapolis MN 55432 3576
• MDR Report Key: 7066833
• MDR Text Key: 93337966
• Report Number: MW5073612
• 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: 36 YR
• Patient Weight: 57