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

Model Number 3058

Device Problems Labelling, Instructions for Use or Training Problem (1318); Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 12/21/2018

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 patient implanted with a neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.The patient reported that when she got the implant it was so much better but at the moment, they had been having so much problems, and was having pain.The patient stated the problems she was having was that she just had a replacement ins on (b)(6) 2018 and she watched the video but did not understand that, and had been using a lot of pads, and was peeing worse than before the battery was ever put in.She indicated when she had the new implant put in, her symptoms were good and that the loss of therapy started yesterday ((b)(6) 2018).The patient was in excruciating pain at the implant site and they did not tell her how to dress it, but she has been dressing it and the doctor had given her pain medication.She clarified that she was currently at the healthcare professional (hcp) office and wanted a representative to come explain how to use the controller.No further complications were reported or are anticipated.

Manufacturer Narrative

Product id 3093-28, lot# v890309, implanted: (b)(6) 2012, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer.It was reported that the circumstances that led to the loss of therapy was due to the leads being lost.They stated that the battery placed and surgery was unsuccessful because of the inability of sensor to work, and that there was a sensor problem.Patient mentioned they will need to back in to get surgery again.They stated that the video did work and there was no video problem.No further complications were reported or anticipated.

Event Description

Additional information was received from patient.They reported that they have been through hell and back.They clarified that they meant the leads got lost as in the leads were not connected.Patient had an ins replacement and then found out the lead was not connected so patient will need another surgery scheduled (b)(6) 2019 to connect the lead.Patient states the reason for a second surgery was probably due to insurance approval.Patient has returned to have the surgery to connect the leads to the device so it can function and do it job.No further complications were reported or anticipated.

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: 8203995
• MDR Text Key: 131920590
• Report Number: 3004209178-2018-28497
• 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: 04/16/2019

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: 04/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 02/25/2019; 04/05/2019
• Supplement Dates FDA Received: 03/21/2019; 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR