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

Model Number	MN10550-50
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 1627487-2022-01851, 1627487-2022-01852, 1627487-2022-01854, 1627487-2022-01855, 1627487-2022-01856, 1627487-2022-01857, 1627487-2022-01858, 1627487-2022-01859.It was reported during an ipg revision (reference 1627487-2022-01845), the physician planned to add an extension to the existing lead so it could be routed to the new ipg pocket.The physician had trouble securing the existing lead to the new extension.As a result, the physician decided not to use the extension, unbury the existing lead and tunnel it to the new ipg site.The surgery was extended 2 hours.
Additional Manufacturer Narrative
The report event of stuck set screw was confirmed.As received, the returned lead extension set screw was found stuck against the retaining washer in the connector assembly due to over-torque condition.The cause of the event is consistent with damage during use.There is adequate information in the clinician's manual that addresses proper loosening and tightening of the set screw.The report event of high impedance was not confirmed.As received, the returned lead extension worked properly and passed test.The cause of the reported event remains unknown.

• 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: 14017880
• Report Number: 1627487-2022-01853
• Device Sequence Number: 19966352
• Product Code: PMP
• UDI-Device Identifier: 05415067027177
• UDI-Public: 05415067027177
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2022
• Device Model Number: MN10550-50
• Device Catalogue Number: MN10550-50
• Device Lot Number: 7563061
• Was Device Available for Evaluation?: Yes
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• 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 LEAD (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 82 KG