MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD WIDE SPACED, 110 CM; SCS LEAD

Model Number	3161
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer reference numbers: 1627487-2022-01837, 1627487-2022-01838, 1627487-2022-01839, 1627487-2022-01841.It was reported that the leads were found to have migrated and fractured during an inoperable ipg replacement (related manufacturer reference number 1627487-2022-00050) on (b)(6) 2022.Imaging confirmed the fracture and migration.As a result, the physician explanted and replaced all peripheral leads with two octrode leads during the same procedure.Post-operatively, stimulation therapy was restored.It is unknown which 4 leads the patient has implanted, therefore all leads are being reported.
Additional Manufacturer Narrative
A patient experiencing lead migration and fracture was reported to abbott.The patient leads were explanted and replaced.Therapy was restored.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 110 CM
• Common Device Name: SCS 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: 13996364
• Report Number: 1627487-2022-01840
• Device Sequence Number: 14537926
• Product Code: LGW
• UDI-Device Identifier: 05414734401647
• UDI-Public: 05414734401647
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• 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): 05/16/2022

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: 04/28/2012
• Device Model Number: 3161
• Device Catalogue Number: 3161
• Device Lot Number: 3114134
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 05/15/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2010
• 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: SCS EXTENSION (X2); SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 82 KG