MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC INTERSTIM ICON; STIMULATOR, ELECTRICAL, IMPLANTABLE

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/04/2016

Event Type  Injury  

Event Description

Patient states that she began experiencing a shocking feeling on the left foot and also had two of her toes curling involuntarily.She then states that in (b)(6), she had to have surgery in order to replace the battery for the interstim due to an electrical short.The battery was said to last 3-5 years yet, failed to last even 1 year.She states that recently she had surgery on (b)(6), to treat a bone spur in her left foot as a result of the interstim.

• Brand Name: MEDTRONIC INTERSTIM ICON
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 7013660
• MDR Text Key: 91872202
• Report Number: MW5073208
• Device Sequence Number: 1
• Product Code: KPI
• 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: 11/08/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 66