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

Model Number	353101
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Stretched (1601); Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id 3889-28, lot#: va23nmc, implanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 01-nov-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer¿s representative (rep) regarding a trial patient who was using an external neurostimulator (ens) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the stage 1 trial was working fine but the day of the call the patient was unable to go above 0.4 ma.It was reviewed that there was a possible connection issue, but the rep was not with the patient for troubleshooting.The rep noted they would meet with the patient the day of the call.It was noted that the trial began on (b)(6) 2019 on a second call, the rep reported the patient had pulled the whole gray wire, the cable disconnected, snapped, and severed.The patient was doing fine, and they did have great success with the trial, so they were going next week for the stage 2 implant.On (b)(6) 2019 the rep reported that the lead was damaged and had migrated from the patient during their trial.The rep indicated that stretching had occurred, and the patient must have gotten it caught on something.The rep reported the damaged lead was removed and a new lead was inserted.No patient symptoms were reported.No further complications were reported.
Additional Manufacturer Narrative
Concomitant medical products: product id: 3889-28, lot# va23nmc, serial# implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the manufacturer¿s representative (rep).The provided the explant date of the device.No further complications were reported/expected.

• Brand Name: VERIFY ENHANCED
• 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: 9445607
• Report Number: 3004593495-2019-01281
• Device Sequence Number: 11363483
• Product Code: EZW
• UDI-Device Identifier: 00643169968783
• UDI-Public: 00643169968783
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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
• Operator of Device: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR