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

Model Number 3058

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Tachycardia (2095); Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3889-28, lot# va0l280, implanted: (b)(6) 2014, product type: lead.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

A patient reported she had been having issues since the device was implanted and she did not know if the issues were with the device or where it was implanted.The physician reportedly had a "really hard time" implanting the device.The device had been causing her heart to race which had gotten worse recently.The patient saw her healthcare provider (hcp) who indicated that the issue was not with the device because the device was off.The patient confirmed that she turned the device off herself.However, the patient did not believe the hcp since the device was in the body and she had issues "right from the start".Additionally, the patient had impulses going through her body which started less than 24 hours of being implanted.This was confirmed to be uncomfortable stimulation.Whenever the device "acted up", it hurt the implant site.The patient was not sure if the issue was with her device or her skin.In the last six months, the pulses had become more "extreme" because she still had pulses going down her right leg and "all the way down to her toes" with stimulation off.The pulses could also be in the patient's right or left hand.The patient saw her hcp approximately 6 weeks prior to the report to have her device checked.The hcp reportedly noticed that "one of the leads" was not working right.The hcp set the device on "2" and "all of a sudden", one day the device "started going crazy again".It was noted that at the time of the report the pulses were "pretty much all over the patient's body" and the patient could feel stimulation in her buttock.The device had been off but it was still hurting.It was confirmed that therapy was off.The patient had an appointment scheduled with her hcp the following day.A week later, the patient indicated that the device was going to be explanted because the hcp determined that it was not helping with the patient's symptoms.However, the patient did not agree because the device was helping her, but it was going "crazy", which was reportedly referring to the previously reported issues.The issues were indicated to have gotten worse 2 days prior and "more stuff happened".There were no falls or trauma associated with these issues.The patient was indicated for urinary dysfunction and gastrointestinal/pelvic floor.

Manufacturer Narrative

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.

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6183012
• MDR Text Key: 62668305
• Report Number: 3004209178-2016-26679
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Date Device Manufactured: 07/08/2014
• 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: 54 YR