MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3023

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown_lead, product type: lead.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a consumer who was implanted with a neurostimulator for gastrointestinal/pelvic floor.The hcp reported that the patient¿s system was not functioning properly and was removed except a fragment of an electrode remains.It was indicated that the implantable neurostimulator (ins) and leads were removed because the #3 bracket broke, so they decided to have it all removed.No further complications were reported or were expected.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7081409
• MDR Text Key: 93679663
• Report Number: 3004209178-2017-24836
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994756558
• UDI-Public: 00613994756558
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2017

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: Health Professional
• Device Expiration Date: 04/14/2015
• Device Model Number: 3023
• Device Catalogue Number: 3023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/04/2017
• Date Device Manufactured: 10/23/2013
• 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