MAUDE Adverse Event Report: PELVIC FLOOR STIMULATOR; STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Model Number	UNSURE
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Headache (1880); Memory Loss/Impairment (1958); Brain Injury (2219); Confusion/ Disorientation (2553); Swelling/ Edema (4577)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Brain encephalomalacia; patient experiencing adverse reactions to catheters that are currently retained in patients body, after several attempts to locate a physician for extraction, patient has been unsuccessful and is experiencing life-threatening problems such as swollen extremities and now has permanent brain damage due to a brain bleed which no doctor has made aware of patient learn by reading the radiology report.Dr.Claims to work for medtronic but it's not searchable as a physician on their website and upon questioning medtronic learned that this company does not hire physicians directly.Patient experiences headaches on a daily basis as well as confusion memory problems concentration problems these are just a few.Upon reviewing ct scan images, patient noticed a small box in lower abdomen located in the pelvic area that has wires for trimming going around their fallopian tube and connect to another box that is lower in the pelvic area.Patient has been switched primary care physician several times since learning about these items should've never been placed to begin with has been accused of being delusional and crazy but has never once been diagnosed with a mental problem.These items should be removed and physician reprimanded for these actions; this is uncalled for and unethical.Fda safety report id# (b)(4).

• Brand Name: PELVIC FLOOR STIMULATOR
• Common Device Name: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
• MDR Report Key: 12788500
• Report Number: MW5105257
• Device Sequence Number: 13571169
• Product Code: KPI
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2021

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?: Yes
• Device Expiration Date: 11/22/2021
• Device Model Number: UNSURE
• Device Catalogue Number: UNSURE
• Device Lot Number: UNSURE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability; Life Threatening; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White