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

Model Number	3156
Medical Device Problem Codes	Battery Problem (2885); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Insufficient Information (4580)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact date of event is unknown.During processing of this incident, attempts were made to obtain complete patient and device information.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.
Event or Problem Description
It was reported that the patient's ipg had died.It is unknown if this occurred prematurely.Surgical intervention occurred on (b)(6) 2023 during which the ipg was explanted and replaced and two new leads were implanted to address the issue.
Additional Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Additional Manufacturer Narrative
Corrected data: the issue regarding ipg inoperable for ipg: 3660 sn (b)(6), lot 6769964 is reported under related manufacturer reference number: 1627487-2023-02096.This report related manufacturer reference number: 1627487-2023-02760 documents/reports the lead explant due to migration.Hence, the section d1, d4, d6, h4 and h6 were corrected in this report to reflect the lead/ migration issue.Additional components potentially involved in the event include: common device name: scs lead, model: 3156, udi: (b)(4), serial:(b)(6), batch:6981414.
Event or Problem Description
Additional information received indicates that the patient experienced ineffective therapy due to one of the occipital leads had migrated.As such, surgical intervention took place wherein the lead was explanted and replaced to address the issue.The second lead was electively replaced as well.Reportedly, therapy was confirmed post op.Investigation was unable to determine which of the leads had migrated.
Additional Manufacturer Narrative
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 incident could not be conclusively determined.

• Brand Name: QUATTRODE LEAD, 3/6MM, 60 CM
• Common Device Name: SCS IPG
• 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: 17110743
• Report Number: 1627487-2023-02760
• Device Sequence Number: 2250635
• Product Code: LGW
• UDI-Device Identifier: 05414734401623
• UDI-Public: 05414734401623
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 01/17/2024

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: 05/08/2021
• Device Model Number: 3156
• Device Lot Number: 6981414
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 06/16/2023; 07/24/2023; 11/08/2023; 12/28/2023; 01/08/2024
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 06/21/2023; 08/16/2023; 12/01/2023; 12/28/2023; 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• 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; SCS IPG; SCS LEAD; SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 71 KG