MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD VERIFY; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3531
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a patient regarding their external neurostimulator (ens).Patient reported that he was on the trial for his bladder that he started 3 weeks ago, and his device was not working, because he was getting a communication error.Patient was asked what patient was seeing on the screen that indicated communication error.Patient reported communication error, serial number, external device battery and it stated that external device battery had depleted, and therapy had stopped.Patient was asked if patient saw a screen number to verify the screen the patient was seeing, but the patient reported it did not give a screen number.It was reviewed with the patient that the patient¿s ens battery might potentially need to be changed and advised the patient to follow up with the healthcare professional (hcp).It was reviewed with the patient that it was not recommended that the patient change the batteries for the ens and that the patient follow up as soon as he can with his hcp that he is working with for the trial.Patient noted during the call that he was currently in the hospital and that his device was not doing any good if the batteries were depleted.No further symptoms or complications reported or anticipated.(b)(6) 2018 (hcp): document contains no new information.

• Brand Name: VERIFY
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 7466052
• Report Number: 3004593495-2018-00428
• Device Sequence Number: 1456415
• Product Code: EZW
• UDI-Device Identifier: 00643169725072
• UDI-Public: 00643169725072
• Combination Product (Y/N): N
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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
• Operator of Device: Health Professional
• Device Model Number: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization