MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD 3/4MM, 30 CM; SCS LEAD

Model Number	3143
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event estimated.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.
Event or Problem Description
It was reported that during an elective ipg replacement that took place on (b)(6) 2024.The system diagnostics recorded high impedances on the cervical lead and was not providing adequate therapy.The cervical lead is not currently connected to the new ipg, and surgical intervention may take place at a future date to address the lead issue and connect it to the new ipg.
Additional Manufacturer Narrative
Date of event estimated.
Event or Problem Description
Additional information was received stating that surgical intervention took place where the lead was explanted and replaced to address the issue.The ipg was also replaced but met longevity.Effective stimulation was restored.
Additional Manufacturer Narrative
Date of event estimated.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: QUATTRODE LEAD 3/4MM, 30 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19005952
• Report Number: 1627487-2024-07818
• Device Sequence Number: 8446243
• Product Code: LGW
• UDI-Device Identifier: 05414734406031
• UDI-Public: 05414734406031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 06/05/2024

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 Model Number: 3143
• Device Lot Number: 35735
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 05/28/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/10/2024; 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 88 KG