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

Model Number	3531
Medical Device Problem Codes	Failure to Interrogate (1332); Battery Problem (2885); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119); Therapeutic Response, Decreased (2271)
Date of Event	08/19/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient had a problem last night.Patient stated after driving yesterday, they were unsure how, but his device stopped working.Upon further inspection, they realized the ens batteries were dead.Patient had already bought the batteries to replace them, but waited to speak with someone first.They confirmed again it was indeed the ens that had dead batteries.Patient had new batteries but had not replaced them yet.Patient stated the first day of evaluation, they saw improvement and was able to void on their own but since ens had been dead, they had not been able to void on their own.Patient did not really get an urgency to void, they just got pain in their kidneys which let them know that they had to go.Premature battery depletion, unable to remain synced to remote or testing cable.Batteries changed in both ens and remote and re synced by technical services, unsuccessful.They tried to sync a new remote to the ens in the office and was unable to get it to stay active.They then replaced the ens with a new one and it worked fine.Patient was advised to consult with doctor for more information.There were no complications or that no further complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.Manufacturer representative reported they resynced the patient remote to the ens and it would not stay bonded.They then tried a different remote with the same result.That is when they changed out ens¿s.The cause of the ens dying was not known.No further information reported/anticipated.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
No new information was reported.
Additional Manufacturer Narrative
Analysis of the(b)(4) verify external neurostimulator (s/n (b)(4)) found no anomaly.If information is provided in the future, a supplemental report will be issued.

• 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: 6861255
• Report Number: 3004593495-2017-00488
• Device Sequence Number: 13748845
• Product Code: EZW
• UDI-Device Identifier: 00643169567764
• UDI-Public: 00643169567764
• Combination Product (Y/N): N
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/29/2017

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: No Information
• Device Model Number: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2017
• Supplement Date Received by Manufacturer: 09/15/2017; 09/21/2017; 11/27/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 09/19/2017; 09/26/2017; 11/29/2017
• 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: Required Intervention
• Patient Age: 37 YR