MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD 3/4MM, 30 CM; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	3143
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: quattrode lead, model: 3143, udi: (b)(4), batch: 38709.
Event or Problem Description
It was reported that the patient was experiencing ineffective stimulation due to high impedances.Surgical intervention is pending to address this issue.The investigation did not determine which lead contributed to this issue.
Additional Manufacturer Narrative
The reported event for high impedances was confirmed.The lead was received complete.Microscopic inspection of the lead revealed all wires were broken at 23.6cm distal to the stimulation end.The broken wires are consistent with an overstress condition the lead was subjected to while in vivo.

• Brand Name: QUATTRODE LEAD 3/4MM, 30 CM
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 17685907
• Report Number: 1627487-2023-04244
• Device Sequence Number: 17712630
• Product Code: LGW
• UDI-Device Identifier: 05414734401579
• UDI-Public: 05414734401579
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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): 11/13/2023

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: 06/28/2007
• Device Model Number: 3143
• Device Lot Number: 38709
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 09/19/2023; 11/07/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/11/2023; 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2005
• 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 IPG.; SCS LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 82 KG