MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) HEADER, DRG EPG; ACCESSORY

Model Number	7032
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	11/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the product was expired but used in a procedure on (b)(6) 2021.
Additional Manufacturer Narrative
Use of product past product expiration date was confirmed.Product was used in a case on monday (b)(6)2021, whereas product expiration was 04nov2021.Based on the review of the complaint, the method used to assign ubd for the product, sterile barrier testing performed, the overall performance of the device, intended use of the device, low probability of occurrence and worst-case risk assessment detailed above, the patient risk for use of a device passed the ubd is occasional.The inventory procedure update to implement device check was not released at the time of procedure.Since the occurrence, the inventory management policy 90557240, rev g was released on 03-feb-2022.No reports of patient adverse impacts.

• Brand Name: HEADER, DRG EPG
• Common Device Name: ACCESSORY
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 13869239
• Report Number: 3006705815-2022-01382
• Device Sequence Number: 5264565
• Product Code: PMP
• UDI-Device Identifier: 05415067027863
• UDI-Public: 05415067027863
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2021
• Device Model Number: 7032
• Device Catalogue Number: 7032
• Device Lot Number: A000089407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRG TRIAL LEAD; DRG TRIAL LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female