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

Model Number 3058

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 05/05/2016

Event Type  malfunction  

Event Description

Interstim neurostimulator was defective and needed to be explanted from the patient.Clinical engineering received both the implant as well as the patient programmer portion of the device.While trying to sync the implant with the programmer in the clinical engineering lab a "call clinician" icon came up with an error code of "por".

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC; 7000 central avenue ne,; rcw225; minneapolis MN 55432
• MDR Report Key: 5690727
• MDR Text Key: 46262341
• Report Number: 5690727
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 61