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

Model Number	305901
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of lead and stylet revealed that body of the lead was stretched and the stylet was able to withdrawn from the lead body.The main component of the system and other applicable components are: product id: 309101, lot# 51026433, implanted: (b)(6) 2017, product type: screening device.Product id: neu_unknown_lead, product type: lead.Product id: neu_stylet_acc, product type: accessory.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 or Problem Description
The manufacturing representative reported that it was not certain which lead was having problems.Both leads were opened at the same time and placed on sterile field by office staff.During the removal of the needle, one of the stylets became stuck inside the lead and could not be removed.So they had to remove the entire lead which caused the patient to be stuck again with another needle.They replaced the lead with another from the same lot, and that stylet was also difficult to remove, but they were able to remove it.The lead was stretched out during the process of removing the stylet.The lead was functional even though it was stretched.Lead had to be replaced and caused an unnecessary needle stick for the patient.They were not sure which lead was the problem, so that was why, they included both and returned the unused product per customer request.Patient was advised to consult with doctor for more information.There were no complications or that no further complications were reported.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): FLEXTRONICS INTERNATIONAL; 019 friesacherstrasse 3; althofen
• MDR Report Key: 6742154
• Report Number: 8030670-2017-00003
• Device Sequence Number: 831514
• Product Code: EZW
• UDI-Device Identifier: 00643169721166
• UDI-Public: 00643169721166
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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
• Operator of Device: No Information
• Device Expiration Date: 03/07/2019
• Device Model Number: 305901
• Device Catalogue Number: 305901
• Device Lot Number: 60058755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR