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

Model Number NEU_INTERSTIM_INS

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: neu_unknown_lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from the healthcare professional (hcp) via the manufacturer representative (rep) reported that there was a tined lead that was removed 2 years ago as the system was not working but a small fragment of the electrode was retained when the tined lead was pulled out.Given, the patient had no system now, the physician was wondering if they could have a mri scan with this small part of the tined lead still in situ.There was a broken electrode during explant.No further complications were reported/anticipated.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• 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: 7642451
• MDR Text Key: 112491947
• Report Number: 3007566237-2018-01913
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2018
• 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