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

Model Number 3058

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Unintended Collision (1429); Malposition of Device (2616); Material Protrusion/Extrusion (2979); Insufficient Information (3190)

Patient Problems Fall (1848); Burning Sensation (2146); Complaint, Ill-Defined (2331); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient¿s device was not working anymore and that they had 2 falls in one night getting out of bed (falls confirmed to be unrelated to the implanted device/therapy).After the fall, just above the patient¿s rectum on the left side, it looked like ¿there¿s a rod trying to push through the skin¿.Additionally, further to the right above that, ¿there¿s a pad of something under the skin and it¿s moving around¿.The family member reported that the patient¿s vagina burns and they could not figure out why.They inquired if it could be related to something hitting the patient¿s nerve.The family member mentioned that the patient had relocated and needed assistance finding a doctor in the area.They were provided with physician listings and the manufacturer¿s representative provided a doctor close to patient.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient's husband.They reported that with the first implant, the patient fell on (b)(6) 2018 and broke their pelvis.They were experiencing a lot of pain and were hospitalized.That (b)(6), a new physician saw the patient and thought that the neurostimulator 'broke loose' due to the fall.They were going to reconnect it, however caller said they were told that it couldn't be repaired, so they removed the complete system and placed new system on the left side.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 7739332
• MDR Text Key: 116097220
• Report Number: 3004209178-2018-17141
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

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: 12/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 04/02/2021
• Supplement Dates FDA Received: 10/04/2018; 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention