MAUDE Adverse Event Report: ABBOTT MEDICAL KIT TRIAL SLIM TIP LEAD, 50CM; DRG TRIAL SLIM TIP LEAD

Model Number	MN10350-50A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that after the patient was implanted with their trial lead they started experiencing severe pain in their c8 lead.Surgical intervention was undertaken and their lead was explanted.
Additional Manufacturer Narrative
Correction b5: additional information received reports that the patient's lead was at c7 and not c8 as previously reported.
Event or Problem Description
Additional information received reports that the patient's lead was at c7 and not c8 as previously reported.

• Brand Name: KIT TRIAL SLIM TIP LEAD, 50CM
• Common Device Name: DRG TRIAL SLIM TIP 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: 16099527
• Report Number: 1627487-2023-00023
• Device Sequence Number: 12301926
• Product Code: PMP
• UDI-Device Identifier: 05415067025517
• UDI-Public: 05415067025517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/11/2023

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 Model Number: MN10350-50A
• Device Catalogue Number: MN10350-50A
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: DRG LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 61 KG