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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 12/02/2016

Event Type  malfunction  

Event Description

A patient with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor reported a change in therapy.The patient began the call with a brief run through of her medical history prior to ins implant and therapy.The patient stated that she was doing ok, but then she started having to wear a pad all the time and has "been having feces and doesn't know why." the patient wondered if it could be related to food.When asked the patient stated that she did not feel stimulation and therapy was on, but after increasing stimulation the patient confirmed that she did feel stimulation in the correct area.The patient wondered it her battery had died, but it was reviewed with the patient that the battery was not dead because the patient was able to sync and adjust settings as expected.The patient stated that she was doing ok a month ago, but the problems got worse "probably in the last 3 or 4 days, at least 3 days." the patient was advised to follow-up with her healthcare provider (hcp) with her symptom and therapy concerns.The patient called back on (b)(6) and reported that yesterday she raised the stimulation to 3.9 on program 1 and it hurt the bottom of her lower butt cheek.The patient also reported that she is still having the same problems and "didn't get much tingling." the patient was assisted in changing to program 2 at 4.0, but still felt stimulation in the lower butt cheek.During troubleshooting the patient encountered the low patient programmer (pp) battery message and that patient stated that she would see if she had more aaa batteries and then try changing to program 3 or 4 to see if stimulation moves to the target area.The patient called back again the same day and repeated information stated above.The patient was now calling for assistance with changing programs after replacement of the pp batteries.The patient stated that she is not sure if she should change programs because right now she is on programs 2 with stim at 4.0, but is only barely feeling stimulation.It was reviewed with the patient that she could try to increase stimulation on the current program and then change programs if the increase in stimulation does not resolve the issues.The patient increased stimulation to 4.4 and confirmed that she does feel stimulation in the correct area.The patient was advised to allow time for the patient's body to adjust to the change in therapy, but if the patient's symptoms/concerns do not resolve the patient should follow-up with her hcp.The patient asked if there was a surgery that could be done so that the patient would no longer need the ins, and it was reviewed with the patient that this would be a discussion to have with her hcp.The patient also mentioned that she knows "a gal" that had issues with her ins as well who had surgery with the same hcp and the patient asked if the manufacturer knew the hcp, the call center reviewed their role and that the call center does not work for hcps.The patient's status is unknown at the time of this report.

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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6215757
• MDR Text Key: 63653912
• Report Number: 3004209178-2016-27471
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2016

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: 11/28/2012
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: 12/06/2016
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2011
• 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 Age: 74 YR