MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Arrhythmia (1721); Diarrhea (1811); Fever (1858); Headache (1880); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Hypoglycemia (1912); Nausea (1970); Tinnitus (2103); Visual Impairment (2138); Irritability (2421); Presyncope (4410); Swollen Lymph Nodes/Glands (4432)

Event Date 12/01/2020

Event Type  Injury  

Event Description

For the last 7-8 years, i have been prescribed bactrim or sulfamethoxazole/tmp for utis.On (b)(6) 2020, i had my pacemaker (medtronic interstim i) removed and a new medtronic interstim ii device was inserted.I was also given a 5 day course of bactrim at that time.Immediately after, i started having nausea, diarrhea, loss of appetite, muscle atrophy, mood changes, aggression, fluctuations in blood sugar, increased heart beat, hypertension, tinnitus, headache, vision loss, and lightheadedness.Due to these side effects, i had to have emergency surgery (beginning of (b)(6)) to remove the device.I am not certain if the side effects could be attributed to bactrim, the device, or both.Since the removal, the flares and symptoms have changed.More prominent symptoms now include tinnitus, headaches, loss of vision, swelling of my lymph nodes, and fever.I have also lost almost 60 pounds in the last year without even trying.And all of the red blood cells elevated.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 12008128
• MDR Text Key: 256774288
• Report Number: MW5101916
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/14/2021

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 46 YR
• Patient Weight: 55