MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B

Model Number	6172
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Fluid Discharge (2686)
Date of Event	11/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
¿date of event¿ is estimated.During processing of this complaint, attempts were made to obtain complete event information.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
Related manufacturer reference numbers: 1627487-2021-18936, 1627487-2021-18937, 1627487-2022-00825.It was reported that the lead site wound had fluid discharge.Additional information was received that the patient had an allergic reaction on the skin of the forehead and around the cranial wound.The patient was prescribed iv antibiotics, surgery may have occurred on (b)(6) 2021 to wash out the wound, and patient was hospitalized to address the issue.The patient was later discharged from the hospital.The issue resolved without sequelae.
Additional Manufacturer Narrative
¿date of event¿ is estimated.During processing of this complaint, attempts were made to obtain complete event information.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
Related manufacturer reference numbers: 1627487-2021-18936, 1627487-2021-18937, 1627487-2022-00825.It was reported that the lead site wound had fluid discharge.Additional information was received that the patient had an allergic reaction on the skin of the forehead and around the cranial wound.The patient was prescribed iv antibiotics, surgery may have occurred on (b)(6) 2021 to wash out the wound, and patient was hospitalized to address the issue.The patient was later discharged from the hospital.The issue resolved without sequelae.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B
• Common Device Name: DBS 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: 13520231
• Report Number: 1627487-2022-00824
• Device Sequence Number: 5312003
• Product Code: MHY
• UDI-Device Identifier: 05415067020680
• UDI-Public: 05415067020680
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2022

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
• Device Expiration Date: 06/27/2022
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 7564701
• 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: 02/07/2022
• Initial Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2020
• 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; Hospitalization
• Patient Sex: Unknown