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

Model Number	041839
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On 2021-aug-12 (b)(4) (rep, hcp, for): information was received from multiple sources (manufacturer representative, healthcare provider) regarding a trial patient.It was reported that patient was admitted for routine stage 1 tined lead sacral neuromodulation trial.Surgeon had a lot of difficulty locating correct area with the needles provided (the 1st step of the procedure).Just before end of surgery was abandoned surgeon requested long needles to be opened.The box was given to the scout nurse and the expiry date was checked out loud.No one realized the expiry date was 5/8/2021.The date of surgery was (b)(6) 2021.The anesthetist by this stage had also scrubbed in to the case and was attempting to locate the correct place with the existing needles.Very soon after this the surgeon abandoned the case.There is no guarantee that the long needles were used in the patient as there were multiple needles available on the trolley and 2 doctors by this stage.Unfortunately due to extreme work stress, recent covid 19 isolation and a sore back i had not noticed the needles had expired by 4 days.The hospital staff had not noticed either despite the staff checking the date.Prior to the case rep had checked mmx report and noted there were no expired items in their trunk stock.No symptoms were reported.¿the surgeon and anaesthetist decided the patient was not suitable for sacral neuromodulation¿therapy due to difficult sacral access.Patient has been recommended for an alternative therapy.The issue was confirmed resolved.

• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): AVAILMED S.A.DE C.V.9; c.industrial lt.001 mz.105; tijuana,bc 22444 ; MX 22444
• MDR Report Key: 12328193
• Report Number: 3010291427-2021-00011
• Device Sequence Number: 4981173
• Product Code: EZW
• UDI-Device Identifier: 00763000114060
• UDI-Public: 00763000114060
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2021
• Device Model Number: 041839
• Device Catalogue Number: 041839
• Device Lot Number: 60200362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR