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

Model Number MN10550-50

Device Problem Mechanical Jam (2983)

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

Event Date 03/15/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2022-01851, 1627487-2022-01852, 1627487-2022-01853, 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.

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
• Type of Device: 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: 14017881
• MDR Text Key: 288786801
• Report Number: 1627487-2022-01854
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027177
• UDI-Public: 05415067027177
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: MN10550-50
• Device Catalogue Number: MN10550-50
• Device Lot Number: 7725891
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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
• Treatment: DRG LEAD (X2)
• Patient Sex: Female
• Patient Weight: 82 KG