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

Model Number 309101

Device Problems Break (1069); Difficult to Remove (1528); Shelf Life Exceeded (1567); Shipping Damage or Problem (1570); Material Deformation (2976)

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

Event Date 03/27/2017

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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional (hcp) via a manufacturer representative reported during a trial procedure, the wire looked like it had a slight kink/bend in it as the outer packaging was opened.When the wire was implanted, it was not possible to remove the introducing needle without stripping the wire.No factors noted to have led to the event.No troubleshooting or actions/interventions were possible.The product was replaced.The issue was noted as resolved.The consumer¿s medical history included fecal incontinence.Additional information received from the representative indicated the implant/explant dates were correct, that it was a few days out of expiration, but they were okay with this.There were no further complications reported and/or anticipated.

Manufacturer Narrative

Analysis of the lead, model (b)(4), found the lead body stretched.Electrical testing of the lead determined continuity was complete.The lead is severely stretched near the distal end.The stylet could move freely in the lead in the areas where it had not been stretched including the electrode area.It was also noted that the stylet wire was slightly bent 6.2 cm from the distal end.There was also damage to the one end of the packaging tube that was used to return the lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Corrected information: sex, no eval explain code.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): 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: 6516013
• MDR Text Key: 73514755
• Report Number: 8030670-2017-00001
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2017

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: Health Professional
• Device Expiration Date: 03/11/2017
• Device Model Number: 309101
• Device Catalogue Number: 309101
• Device Lot Number: 0211313209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/24/2017
• Supplement Dates Manufacturer Received: Not provided; 05/03/2017
• Supplement Dates FDA Received: 05/11/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2016
• 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