MAUDE Adverse Event Report: MPRI INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3889-28
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2018
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 health care professional via a manufacturer representative (rep) regarding an implantable neurostimulator (ins).It was reported that during stage 1 and 2, blood got inside the tined lead before deploying the tines and the lead was never implanted.The doctor suspected the possibility of the lead being faulty or compromised and chose to get a brand new lead to implant.No further complications were reported.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be submitted when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
(b)(4).Upon receipt, visual inspection noted fluid consistent with body fluids in the lead.Each conductor is individually insulated so there was no impact on the lead or lead performance.Electrical testing determined that continuity was complete and there were no electrical shorts between the circuits.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Product id: neu_stylet_acc, lot# unknown, product type: accessory; product id: neu_stylet_acc, lot# unknown, product type: accessory.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Device analysis,.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7734555
• Report Number: 2649622-2018-12424
• Device Sequence Number: 19237114
• Product Code: EZW
• UDI-Device Identifier: 00643169887923
• UDI-Public: 00643169887923
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 02/08/2022
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1NYYW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 07/23/2018; 08/28/2018; 08/08/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/15/2018; 09/20/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR