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

Model Number	305901
Medical Device Problem Codes	Difficult to Remove (1528); Device Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: product id: neu_stylet_acc, serial# unknown, product type: accessory.Product id: neu_stylet_acc, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a manufacture representative (rep).It was reported there was a kinked lead.The rep stated the stylet in the basic evaluation lead would not come out of the lead.The rep noted there may have been a kink in the stylet.The hcp attempted to removed, but they were unable to.The rep noted the lead was replaced and the issue was resolved at the time of the report.The rep noted when attempting to place the lead during a basic evaluation the hcp inserted the lead and when he tried to remove the stylet, it would not move.The hcp tried again and the top plastic on the stylet popped off.The hcp was unable to remove and replaced the lead with another lead that had the same lot number.It was noted the lead would be returned.There were no further complications that have been reported as a result of this event.
Event or Problem Description
Additional information received from rep again reporting that the lead kinked and was unable to be used.They had to replace it.No patient death, no patient injury and patient recovered without sequela.Lead had been sent in and received by medtronic.No further complications were reported.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the lead model 305901 lot # 60088981 showed the body of the lead conductors were stretched.Electrical testing of the product determined the continuity was complete.It was noted that the stylet wire had perforated the body of the lead.The wire insulation was intact.Analysis of the stylet accessory model unknown, serial # unknown showed no significant anomalies.Analysis also showed the stylet wire was bent.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): FLEXTRONICS INTERNATIONAL; 019 friesacherstrasse 3; althofen
• MDR Report Key: 7481561
• Report Number: 8030670-2018-00002
• Device Sequence Number: 16478666
• Product Code: EZW
• UDI-Device Identifier: 00643169721166
• UDI-Public: 00643169721166
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2018

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
• Operator of Device: No Information
• Device Expiration Date: 08/09/2019
• Device Model Number: 305901
• Device Catalogue Number: 305901
• Device Lot Number: 60088981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018; 06/06/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 05/23/2018; 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR