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

Model Number 305901

Device Problem Bent (1059)

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

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Information was received from a healthcare professional via a manufacturer¿s representative regarding a percutaneous lead for a trial prior to implant.It was reported that prior to deploying the test lead, the doctor noticed the lead was bent at the tip; they still tried to use the lead and were unable to deploy.There was no patient injury and the lead was not used in the patient.No further complications were reported or are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received.Manufacturer representative reported they tried to use the lead on the patient, the stylet would not deploy the lead, due to the bend in it.The physician reportedly noticed the bend prior to putting it in, but thought it was worth trying.No further information reported.

Manufacturer Narrative

Analysis of the lead (#60069683) identified that the body of the lead was stretched.If information is provided in the future, a supplemental report will be issued.

Event Description

Lead was evaluated.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): FLEXTRONICS INTERNATIONAL; 019 friesacherstrasse 3; althofen
• Manufacturer (Section G): FLEXTRONICS INTERNATIONAL; 019 friesacherstrasse 3; althofen
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6927230
• MDR Text Key: 89943775
• Report Number: 8030670-2017-00007
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00643169721166
• UDI-Public: 00643169721166
• 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: 11/10/2017

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: No Information
• Device Expiration Date: 06/01/2019
• Device Model Number: 305901
• Device Catalogue Number: 305901
• Device Lot Number: 60069683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/07/2017
• Supplement Dates Manufacturer Received: 10/11/2017; 11/08/2017
• Supplement Dates FDA Received: 10/13/2017; 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• 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
• Patient Age: 53 YR