MAUDE Adverse Event Report: AVAILMED S.A.DE C.V.9 INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	306001
Medical Device Problem Codes	Difficult to Insert (1316); Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding a patient undergoing a basic evaluation trial.The rep reported that the evaluation lead was stretched out too far that the loaded stylet would not go back in.There were no patient complications reported as a result of this event.Additional information was received from a manufacturer representative (rep).The rep reported that there was no patient symptoms/harm that occurred in relation to the event.The rep clarified that the lead was stretched out too far and would not return to it's original length.The cause of the lead stretching was reported to be due to physician handling.A new lead had been successfully implanted at the time of the event.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): AVAILMED S.A.DE C.V.9; c.industrial lt.001 mz.105; tijuana,bc 22444 ; MX 22444
• MDR Report Key: 10328413
• Report Number: 3010291427-2020-00014
• Device Sequence Number: 19677127
• Product Code: EZW
• UDI-Device Identifier: 00763000114077
• UDI-Public: 00763000114077
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2020

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: Health Professional
• Device Expiration Date: 12/02/2021
• Device Model Number: 306001
• Device Catalogue Number: 306001
• Device Lot Number: 60217388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR