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

Model Number 3023

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 3093, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (via a manufacturer representative) regarding a patient who was implanted with a neurostimulator.It was reported that the patient had a surgery to remove the system so an mri could be done.During the removal of the lead, it was noted that the last 2 distal contacts stayed within the patient.The healthcare professional also stated that the insulation came out with the rest of the lead.At the time of the report, the patient's information was unknown.There were no further complications or anticipations reported with this event.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7347802
• MDR Text Key: 102716412
• Report Number: 3007566237-2018-00817
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2018

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: Health Professional
• Device Model Number: 3023
• Device Catalogue Number: 3023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention