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

Model Number 3058

Device Problem Pocket Stimulation (1463)

Patient Problems Therapeutic Effects, Unexpected (2099); Anxiety (2328); Insufficient Information (4580)

Event Date 11/10/2020

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 who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient just received a new implant today and said that the stimulation is in the butt area not in the front.Patient said that the rep said to program so that it is midline to the vaginal area.Patient said that the rep reviewed everything very quickly right after the procedure when patient recovering from anesthesia and hightailed it out.Patient is very upset and said that, with the exception of program 3, the stimulation sensation on all other programs was in her back where the neurostimulator was placed.Patient said that program 3 is a little forward.Patient again, said is very upset that this wasn't programmed correctly beforehand.The issue was not resolved through troubleshooting.

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.

Event Description

Additional information was received from a health care professional (hcp) via a manufacturer representative (rep).The rep reported that the cause of the stimulation being felt at the neurostimulator site as well as what most likely caused or contributed to the stimulation being felt at the neurostimulator site was unknown.In response to the inquiry for what steps had been or would be taken to resolve the issue and if the issue had been resolved, the rep replied that the patient was currently on program 3 and it was felt approximately in their ¿bicycle seat area/butt.¿ the rep reported that the patient had been scheduled for a 7 am surgery and that they had arrived at the surgery center at around 6 am.The rep stated that the patient had been thoroughly educated before their procedure with plenty of time for review and questions.The rep stated that post-operatively they had spent time with the patient again, answering the patient¿s questions and re-educating.The rep also mentioned that the patient had stated multiple times that they were anxious.No further complications were reported at this time.

• 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
• MDR Report Key: 10836789
• MDR Text Key: 219368801
• Report Number: 3004209178-2020-19950
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

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: 02/28/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR