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

Model Number 3889-28

Device Problems Break (1069); Peeled/Delaminated (1454); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received by a rep regarding an external neurostimulator (ens).The leads plastic protective covering broke during the stage 2 while trying to disconnect the lead extension.Physician was pulling on it so he could access the braided portion of the extension so he could cut it.During the process of disconnecting the lead extension, the plastic tubing on the lead that protects the wire, broke and slid down, exposing the wires.They pulled the lead and implanted a new one during this procedure.The device was explanted completely and will be returned.The issue was resolved at the time of this report.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Continuation of medical devices: product id neu_perc_extension, product type extension.Lead with lot number va1seg8 revealed analysis of conductor # 3 broken(overstress) at 2.5 cm and 9.4 cm from distal end.Conductor wire(s) {was//were} broken due to overstress/damage; in the body of the extension; consistent with overstress damage.And no electrical shorts were identified between the circuits.Neu_perc_extension lot# unknown analysis identified that the {x} conductor(s) was/were broken in the body of the extension; consistent with overstress damage and no electrical shorts were identified between the circuits.During visual analysis of the extension, it was noted the proximal end was not returned.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: 7823923
• MDR Text Key: 118467818
• Report Number: 2649622-2018-14070
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00643169864436
• UDI-Public: 00643169864436
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2022
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1SEG8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR