MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 353101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seizures (2063); Complaint, Ill-Defined (2331); Abdominal Cramps (2543)

Event Date 03/19/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a basic evaluation trial patient with an external neurostimulator (ens) for fecal incontinence and urge incontinence.A basic evaluation patient wanted to know how soon the hurting would go away, as their "butt" was sore from the procedure.The patient was advised to speak to their health care physician (hcp) about this issue.On (b)(6) 2020, the patient left a voicemail stating that they had been having ¿a lot of cramping int their stomach,¿ due to a seizure they had on thursday ((b)(6) 2020), which was the start date of their trial.The patient continued that everything was ¿looking pretty good,¿ but they stated ¿i guess i am putting out more water than i am supposed to be,¿ and that they were wanting to speak to a health care physician (hcp) regarding this.Patient services made an outbound call to the patient to clarify and redirect the patient to their hcp to have their concerns addressed.When patient services asked for clarification the patient confirmed that they had already seen the hcp and had the device checked and ¿everything was working¿ as intended.During the call the patient¿s family member assisted in answering some questions and provided the hcp information.There were no further complications reported.

• Brand Name: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9892400
• MDR Text Key: 196738173
• Report Number: 2182207-2020-00085
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• 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: 03/27/2020

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: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 03/27/2020
• 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): Other
• Patient Age: 82 YR