MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

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

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 3889-28, lot# va16y1l, implanted: (b)(6) 2016, product type lead.Date of the event was estimated.(b)(4).

Event Description

Information was received from a consumer and health care professional regarding a patient implanted with a neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient's unit broke in half 1.5 months after it was implanted and it was clarified that it felt like it stopped working for the patient.It was stated that the patient went in and had to keep having the setting changed to get it to work but it never did.The patient was also given botox injections by the health care professional (hcp), but they were not effective either like the ins therapy had been.It was reported that the patient was also getting ankle stimulation.The caller stated that the hcp told the patient that the device should be removed if it wasn't going to help so the hcp surgically explanted the ins.It was mentioned that during surgery, the hcp found that the device was broken and it was confirmed that the patient had not fallen or anything.The caller also stated that the hcp did not want to make another incision to remove the lead at that time so the lead was left implanted because the hcp told the caller that the patient could be paralyzed if the lead was removed.Additional information was received and it was reported that the lead seemed to have separated from its insertion and tried leads as it pulled out with no effort.There were no further symptoms or complications reported or anticipated.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 3889-28 lot# va16y1l implanted: (b)(6)2016 product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the health care professional did not determine the cause of the lead remaining in the patient.There were no symptoms or complications reported or anticipated.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 7210198
• MDR Text Key: 97943905
• Report Number: 3004209178-2018-01124
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

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: 12/14/2017
• 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: 01/02/2018
• Initial Date FDA Received: 01/22/2018
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 02/02/2018
• Date Device Manufactured: 06/16/2016
• 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: 73 YR