MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 44C LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD

Model Number	3245
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	12/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 1627487-2023-00278.It was reported that the patient experienced undesired nerve stimulation and discomfort at the ipg site.As a result, surgical intervention was undertaken on an unknown date wherein the entire system was explanted to address the issue.It is unknown which lead is liable.
Additional Manufacturer Narrative
Date of event is estimated.The allegation is against 1 of 3 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 wide spaced, 30 cm, model: 3163ans, udi: (b)(4), serial: n/a, batch: 3773645.Common device name: quattrode lead wide spaced, 30 cm, model: 3163ans, udi: (b)(4), serial: n/a, batch: 3773645.
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: LAMITRODE 44C LEAD KIT, 60CM LENGTH
• Common Device Name: SCS PADDLE 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: 16238073
• Report Number: 1627487-2023-00279
• Device Sequence Number: 6454037
• Product Code: LGW
• UDI-Device Identifier: 05414734402088
• UDI-Public: 05414734402088
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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
• Report Date (Section B): 02/02/2023

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: 06/28/2014
• Device Model Number: 3245
• Device Catalogue Number: 3245
• Device Lot Number: 3736458
• 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: 12/29/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2012
• 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 LEAD (X2).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 77 KG