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

Model Number	3531
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id 3889-28, lot# va1h675, implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type lead.Product id 357625, product type screening device.Device code (b)(4) and patient code (b)(4) pertain to the lead (va1h675).Patient code (b)(4) and device code (b)(4) pertain to the 357625 screening device.
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding an advanced evaluation trial patient.The rep reported that the patient experienced an infection due to a prolonged advanced evaluation.The risks of prolonging the evaluation were discussed with the physician and patient by the rep.However, both the physician and patient elected to prolong the test.As a result, an infection occurred which was likely due to the time of the test.The test was 7 weeks long which was 5 weeks beyond medtronic and fda protocol.It was indicated that the patient continued to work daily and as a result would perspire throughout the day.The patient changed their dressing at home several times against initial direction and it was assumed that bacteria was introduced to the site because of this.The rep noted that they were present in the office, on or about on (b)(6) 2017, when the patient was seen by the hcp as a follow-up to their initial stage one.The rep noted that the patient informed them that they had already redressed the percutaneous lead site and that their son had accidently cut the twist lock cable.The cable was replaced and re-dressed by the staff on site.The risk of infection was emphasized clearly to both the physician and patient, but they elected to prolong the test.It was indicated that the physician removed the leads on (b)(6) concluding the test phase and that the patient was given antibiotics to treat the infection.No further complications were reported or were expected.
Additional Manufacturer Narrative
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: 6805768
• Report Number: 3004593495-2017-00487
• Device Sequence Number: 11115905
• Product Code: EZW
• UDI-Device Identifier: 00643169725072
• UDI-Public: 00643169725072
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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: 08/09/2017
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 04/13/2020
• 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: 54 YR