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

Model Number 3058

Device Problems Electromagnetic Interference (1194); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Micturition Urgency (1871); Neuropathy (1983); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Electric Shock (2554); Alteration In Body Temperature (2682)

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 13-dec-2016, udi#: (b)(4), implanted: (b)(6) 2013, product type: lead.(b)(4).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 did not think that their device was working correctly.They stated that they had the device checked out by their healthcare professional (hcp) roughly a year ago and was told it was working fine.The patient further stated that they experienced ¿certain symptoms¿ that they did not think were right and wanted to see if these were normal.They were not sure if they should have the device taken out or not.The patient stated that they had to turn the stimulation ¿way, way up¿ now in order to feel anything, which they never had to do.They turned it all the way up to 7 and tried it at that level on all 4 programs.They stated that if they moved to a certain position with the stimulation this high, it was ¿too much of a jolt/shock sensation¿ so they had to turn it down to under 5.The shocking occurred in the perianal/anus are a.Before this, the therapy was working around 4.This issue started ¿maybe a year ¿ year and a half ago).The patient reported that the lead ¿wires¿ were ¿sticking out at the spine¿ and, if they pushed on it, they felt an ¿electrical sensation¿.This started ¿at least a year ago¿.If it was broken and when they pushed ¿it together¿ it seemed to work on which led them to believe it was kinked or broken.They further stated that sometimes the therapy worked and then sometimes ¿it absolutely is not working because he has a return of urgency bladder symptoms¿.The return of symptoms issue started ¿roughly¿ in 2017.This was intermittent and they thought that it might be due to the previously described issues or maybe it was from them changing the settings and turning the stimulation on/off so much.As an medical test/emi exposure that could be related to the issue, the patient stated that they had 2 mris (2 and years ago) for their neck problems and they experienced the aforementioned symptoms.Additionally, the patient reported that they had neuropathy in their feet and they were cold all the time.This started in the later part of 2018 (maybe (b)(6)).They have been told the cause and the patient did not know if this issue was related to the implanted device/therapy or not.The patient was to follow up with their healthcare professional (hcp) for the issues.There were no further complications reported or anticipated.

• 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: 8382990
• MDR Text Key: 141339993
• Report Number: 3004209178-2019-04331
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2019

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: 05/28/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/01/2019
• Date Device Manufactured: 12/11/2012
• 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