MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD, 3/6MM, 60 CM; SCS LEAD

Model Number	3156
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Initial reporter phone number: (b)(6).
Event or Problem Description
It was reported that both of the patient was experiencing ineffective therapy due to high impedances on both their quattrode leads.As a result, the patient underwent surgical intervention to address the issue.During the procedure, it was observed that the patient's octrode lead was fractured.In turn, all 3 leads were explanted and replaced.Effective therapy was established post-operatively.
Additional Manufacturer Narrative
The report event of high impedance was not confirmed.As received, electrical testing showed the returned terminal and stim end segments lead 3156 (a) were passed isolation resistant testing.

• Brand Name: QUATTRODE LEAD, 3/6MM, 60 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: 20483501
• Report Number: 1627487-2024-11458
• Device Sequence Number: 14496567
• Product Code: LGW
• UDI-Device Identifier: 05414734401623
• UDI-Public: (01)05414734401623(10)6289709(17)200130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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 Expiration Date: 01/30/2020
• Device Model Number: 3156
• Device Catalogue Number: 3156
• Device Lot Number: 6289709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2018
• 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 Sex: Unknown