MAUDE Adverse Event Report: ABBOTT MEDICAL KIT LEAD EXTENSION, 50CM; DRG EXTENSION

Model Number	MN10550-50
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer reference number:1627487-2022-02837 and 1627487-2022-02838.It was reported that during surgical procedure for lead migration (related manufacturer reference number: 1627487-2022-02835, 1627487-2022-02834), the physician was unable to re-implant an extension.During the attempt, the lead extension broke when advancing the lead into the extension.Three extensions were opened.It is unknown which lead extension is related to the issue.Therefore all extensions are being reported.Therapy was established post-operatively, reportedly.
Additional Manufacturer Narrative
A patient experienced an extended procedure was reported to abbott.It was determined that during a lead revision for lead migration, the physician was unable to re-implant an extension.During the attempt, the lead extension broke when advancing the lead into the extension.Three extensions were opened.It is unknown which lead extension is related to the issue.Therefore all extensions are being reported.Therapy was restored.The procedure was extended by about 60 minutes.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information provided, a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: KIT LEAD EXTENSION, 50CM
• Common Device Name: DRG EXTENSION
• 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: 14468363
• Report Number: 1627487-2022-02836
• Device Sequence Number: 4515679
• Product Code: PMP
• UDI-Device Identifier: 05415067027177
• UDI-Public: 05415067027177
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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: 03/31/2023
• Device Model Number: MN10550-50
• Device Catalogue Number: MN10550-50
• Device Lot Number: 7909298
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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 IPG; DRG LEAD EXTENSION X2
• Patient Sex: Female
• Patient Weight: 113 KG