MAUDE Adverse Event Report: NEURO - VILLALBA INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3889-33
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Peeled/Delaminated (1454); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received by a manufacture representative (rep) regarding lead.It was reported that as the lead was examined during procedure the lead and the exterior coating/insulation had clearly separated from the most distal end of the proximal electrodes.They noticed the damaged of the lead and was replaced.They opened a new lead kit and use the new lead.No signs or symptoms as we replaced the lead during the procedure.The issue was resolved at the time of this call.
Additional Manufacturer Narrative
Updated device code: (b)(4) no longer applies.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the representative indicated that the device was examined during the procedure by the physician, scrub and rep, (hence taking a picture of it) to show the lead issue.The weight of the patient was clearly marked in the chart but no verbal communication during the procedure was noted.Representative have not yet shipped the device and needs assistance with shipment.
Additional Manufacturer Narrative
Analysis: analysis of the lead (lot#va0w73c) found the butt joint of the outer insulation was separated at the proximal end of the lead.Analysis of the stylet (lot#unknown) found the stylet wire was bent {x} cm from the {distal/proximal} end.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
No new information.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 8089982
• Report Number: 6000153-2018-00019
• Device Sequence Number: 16503292
• Product Code: EZW
• UDI-Device Identifier: 00613994752437
• UDI-Public: 00613994752437
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/19/2019

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 Expiration Date: 05/29/2019
• Device Model Number: 3889-33
• Device Catalogue Number: 3889-33
• Device Lot Number: VA0W73C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 01/14/2019; 04/18/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 11/20/2018; 01/15/2019; 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR