MAUDE Adverse Event Report: MEDTRONICS, INC. KT LEAD INTERSTIM SURECAN 28CM - LOG2817881; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Lot Number VA2RLLA

Device Problem Use of Device Problem (1670)

Patient Problems Vomiting (2144); Discomfort (2330)

Event Date 06/28/2023

Event Type  malfunction  

Event Description

Patient states she is very uncomfortable and complaints of feeling like she is getting "zapped".Rep was here with the patient at the time attempting to program device.Patient discharged home however, had the interstim device removed a few days later due to continued feeling of being zapped and was vomiting from it.

• Brand Name: KT LEAD INTERSTIM SURECAN 28CM - LOG2817881
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONICS, INC.
• MDR Report Key: 17288485
• MDR Text Key: 318764744
• Report Number: MW5119233
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VA2RLLA
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White