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

Model Number 3058

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 3093-33, serial/lot #: (b)(4), ubd: (b)(6) 2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care professional (hcp) via manufacturer representative (rep) regarding a patient implanted with a neurostimulator for gastrointestinal/pelvic floor.It was reported that while removing the lead, the lead broke and a portion remained in the patient.The rep stated that the hcp was removing the lead, the lead broke, and the distal portion with the tines remained in the patient.It was noted that the hcp was wondering whether the patient could get an mri.There were no further symptoms or complications reported or anticipated.

Manufacturer Narrative

Information references the main component of the system.Other applicable components are: product id (b)(4) lot# v764771 serial# implanted: (b)(4) 2011 explanted: (b)(4) 2018 product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the rep/hcp clarified that the reason the lead was being removed was due to the patient needing an mri.There were no further symptoms or complications reported or anticipated.

• Brand Name: INTERSTIM II
• 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: 7490788
• MDR Text Key: 107594041
• Report Number: 3004209178-2018-10231
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/15/2018

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 Expiration Date: 11/28/2012
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 05/15/2018
• Date Device Manufactured: 06/01/2011
• 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 Age: 81 YR