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); Malposition of Device (2616)

Patient Problems Therapeutic Effects, Unexpected (2099); Device Embedded In Tissue or Plaque (3165)

Event Date 12/22/2009

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3889-28, lot#: v358329, implanted: (b)(6) 2009, explanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with a neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation.It was reported that the patient's implant never really worked for her and the implanted system (ins and lead) were removed.The patient stated that the device was explanted on (b)(6) 2017.Additional information from a consumer regarding a patient on (b)(6) reported the implant never really worked most likely due to the placement of the leads.The patient stated it was in and on for approximately 8 years and enhancing the setting did not make any difference.The patient stated the understood now that before the device was implanted that the trial testing was done.The patient added it would have been nice to have the trial as it would have prepared them for what having the device implanted and running actually entails.The patient stated they were unaware of many things about the device prior to the surgery.The patient noted the implant and lead wires were removed on (b)(6) 2017 at (b)(6) medical center in (b)(6).The patient stated the lead terminal clamps did not come out with the lead wires.The patient stated they had the implant, so they did not know where it was.The patient added they had the battery-operated control.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the healthcare professional (hcp) on january 17th reported the cause of the lead wire breaking when it was removed was unknown.The hcp stated they placed the appropriate tension and it parted leaving the tined position of the lead in place.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 3889-28 lot# v358329 serial# implanted: 2009-(b)(6)explanted: 2017-(b)(4) product type leadif information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the lead wire broke as it was being removed.There were no symptoms or further 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: 7178825
• MDR Text Key: 96872789
• Report Number: 3004209178-2018-00542
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: 00613994287724
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2018

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 Expiration Date: 04/28/2011
• 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: 01/08/2018
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 01/11/2018; 01/17/2018
• Supplement Dates FDA Received: 01/16/2018; 01/18/2018
• Date Device Manufactured: 10/30/2009
• 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
• Patient Age: 50 YR
• Patient Weight: 77