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

Model Number 3143

Device Problem High impedance (1291)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 02/28/2024

Event Type  Injury  

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 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.

• Brand Name: QUATTRODE LEAD 3/4MM, 30 CM
• Type of Device: 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
• MDR Text Key: 338942791
• Report Number: 1627487-2024-07818
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734406031
• UDI-Public: 05414734406031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Female