MAUDE Adverse Event Report: ABBOTT MEDICAL KIT TRIAL SLIM TIP LEAD, 50CM; DRG TRIAL SLIM TIP LEAD

Model Number MN10350-50A

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2021

Event Type  malfunction  

Event Description

It was reported that a demo lead was implanted during a trial procedure on (b)(6) 2021.Further follow-up indicates the packaging was intact and was not labeled as "not intended for human use." the trial was successfully completed and the device was removed on (b)(6) 2021.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information.A "demo product" was not confirmed and further follow-up indicates the packaging was intact and was not labeled as "not intended for human use." no devices were returned for evaluation.As a result, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances present that could have contributed to this issue.Additionally, review of records indicates this device was sterilized and is a finished good for human use.The device was incorrectly denoted as "demo" in sap/sales force during billing.Based on the information received, the device was in conformance at shipment and is in fact a device manufactured for human use.

• Brand Name: KIT TRIAL SLIM TIP LEAD, 50CM
• Type of Device: DRG TRIAL SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12461791
• MDR Text Key: 271098168
• Report Number: 1627487-2021-16939
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027139
• UDI-Public: 05415067027139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: MN10350-50A
• Device Catalogue Number: MN10350-50A
• Device Lot Number: 7208502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male