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

Model Number	306001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4) : analysis information - (b)(6) 2020 11:27:42.Cst.Pli# 10 product id# 306001 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the body of the lead was stretched.Analysis identified the {x} electrode at the distal end of the lead was bent.Concomitant medical products: product id: neu_stylet_acc, lot# unknown, product type: accessory.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider regarding a trial patient who was using an external neurostimulator (ens) for unknown indications for use.It was reported that the lead would not feed into the stylet.No other information was provided.

• 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: 11142440
• Report Number: 3010291427-2021-00001
• Device Sequence Number: 2140434
• Product Code: EZW
• UDI-Device Identifier: 00763000114077
• UDI-Public: 00763000114077
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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: 02/09/2022
• Device Model Number: 306001
• Device Catalogue Number: 306001
• Device Lot Number: 60226084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1