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

Model Number 3058

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

Patient Problems Stroke/CVA (1770); Incontinence (1928); Unspecified Infection (1930); Therapeutic Effects, Unexpected (2099); Urinary Tract Infection (2120)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation.It was reported that device did not work and the patient had not used the implant for years because it did not work; it was unknown when the device stopped working.It was noted the patient was using an ocital patch to help with their incontinence instead.No further complications were reported/anticipated.

Manufacturer Narrative

Additional review determined (b)(4) no longer apply to this event.Due to this correction it was determined the event is no longer reportable as a serious injury, but is reportable for malfunction.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Other applicable components are: product id 3889-28 lot# v249006 implanted: (b)(6)2009 product type lead.Device code (b)(4) applies to interstim ii and lead (lot# v249006).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the family member.Caller said the patient was recently in the hospital where the neurologist thought the patient might have had a mild stroke "resulting from several subsequent bladder infections;" the healthcare provider (hcp) wants the patient to do an mri.The caller then said the patient "doesn't exhibit signs of a stroke" and then further said the patient has had bladder infections "off and on" for about six months.The patient will be prescribed an antibiotic by their hcp which would eliminate the bladder infection, but it would reappear.The patient will have to remove the system because "they haven't used it in years.They never really mastered it, never really worked well, and never helped incontinence.They saw a manufacture representative (rep) who tried to educate them and make it work, but it didn't;" the decision was to abandon the system.No further patient complications have been reported as a result of this event.

• 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: 7054528
• MDR Text Key: 93120289
• Report Number: 3004209178-2017-24295
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: 00613994287724
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2018

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: 05/14/2010
• 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: 11/22/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 11/27/2017; 01/05/2018
• Supplement Dates FDA Received: 11/29/2017; 01/08/2018
• Date Device Manufactured: 11/18/2008
• 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): Hospitalization; Other; Required Intervention