MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD VERIFY; STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION

Model Number 3531

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

Patient Problem Diarrhea (1811)

Event Date 06/17/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The trial patient (day 4 of be - basic evaluation - dos of procedure: (b)(6)) reported that they were experiencing diarrhea.The patient was feeling stim comfortably.The patient had already informed doctor.Pt stated that a nurse would be seeing pt today.Additional information from the healthcare provider (hcp) reported the patient was offered multiple appointments to have the leads removed.Eventually the patient went in and all temporary leads were removed.It was unclear when the leads were removed and if it was the end of the trial.It was noted the patient had an additional follow up with hcp on (b)(6) 2016.

• Brand Name: VERIFY
• Type of Device: STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5837000
• MDR Text Key: 50858780
• Report Number: 3004593495-2016-00300
• Device Sequence Number: 1
• Product Code: NAM
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2016

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?: No
• Device Operator: No Information
• Device Model Number: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 08/01/2016
• Date Device Manufactured: 05/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention