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

Model Number	3889-33
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the lead model 3889-33 lot # va1mgrh showed part of the percutaneous extension was sticking out of the inner tray but was still inside the outer tray.Analysis found the inner lid was loose allowing component movement in the inner tray of the lead kit packaging.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer regarding a patient who was implanted with a neurostimulator for unknown interstim therapy.It was reported that the lead¿s sterile packaging was opened in the or and the lead extension wire was inside the glued area.Sterility could not be guaranteed.Therefore, a new lead was opened and used for implantation.There were no further complications reported.
Additional Manufacturer Narrative
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.

• 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: 7381604
• Report Number: 2649622-2018-02757
• Device Sequence Number: 10795282
• Product Code: EZW
• UDI-Device Identifier: 00643169887930
• UDI-Public: 00643169887930
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 12/08/2021
• Device Model Number: 3889-33
• Device Catalogue Number: 3889-33
• Device Lot Number: VA1MGRH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 07/11/2018; 08/08/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 07/11/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1