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

Model Number	3156
Medical Device Problem Codes	High impedance (1291); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Insufficient Information (4580)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of adverse event is estimated.During processing of this incident, attempts were made to obtain complete event and device information.Further information was requested but not received.
Event or Problem Description
Related manufacturer reference number: 1627487-2023-01723.It was reported that the patient¿s peripheral lead and ipg were explanted and replaced for an unknown reason.
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.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.Corrected data: d1 - brand name.
Event or Problem Description
Additional information received indicates the lead was either implanted in 2013 or 2014.Exact date of implant unable to be obtained.
Event or Problem Description
Related manufacturer reference number: 1627487-2023-01626, related manufacturer reference number: 1627487-2023-01724.Additional information received indicates that the patient's lead had high impedance resulting in ineffective therapy and the ipg was electively replaced.Reportedly, effective therapy was achieved post op.
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: PERCUTANEOUS 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: 16728494
• Report Number: 1627487-2023-01722
• Device Sequence Number: 6862846
• Product Code: LGW
• UDI-Device Identifier: 05414734401623
• UDI-Public: 05414734401623
• 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: 2013
• Device Explanted Year: 2023
• 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,Followup,Followup,Followup
• Report Date (Section B): 09/13/2023

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: 08/28/2013
• Device Model Number: 3156
• Device Lot Number: 3479492
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023; 06/19/2023; 07/24/2023; 08/27/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/11/2023; 07/13/2023; 08/16/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2011
• 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