MAUDE Adverse Event Report: ABBOTT MEDICAL KIT LEAD EXTENSION, 50CM; DRG EXTENSION

Model Number	MN10550-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of the event is estimated.
Event or Problem Description
Related manufacturer reference number: 1627487-2021-17439, 1627487-2021-17440, 1627487-2021-17441.It was reported the patient experienced an infection at the extension site.Surgical intervention took place in which the entire system was explanted 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. .
Event or Problem Description
Additional information received indicates the patient did not have an infection however did have necrotic tissue.

• Brand Name: KIT LEAD EXTENSION, 50CM
• Common Device Name: DRG EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12569191
• Report Number: 1627487-2021-17442
• Device Sequence Number: 19847111
• Product Code: PMP
• UDI-Device Identifier: 05415067027177
• UDI-Public: 05415067027177
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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: 03/12/2020
• Device Model Number: MN10550-50
• Device Catalogue Number: MN10550-50
• Device Lot Number: 6346744
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL # MN10550-50 - EXTENSION (X3); MODEL # MN10550-50 - EXTENSION (X3)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Weight: 91