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

Model Number 3889-33

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2018

Event Type  malfunction  

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 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7381604
• MDR Text Key: 103827460
• Report Number: 2649622-2018-02757
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00643169887930
• UDI-Public: 00643169887930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 08/08/2018
• Supplement Dates FDA Received: 07/11/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1