MAUDE Adverse Event Report: ABBOTT MEDICAL DBS LEAD

Model Number 6172

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Fluid Discharge (2686)

Event Date 11/20/2021

Event Type  Injury  

Manufacturer Narrative

¿date of event¿ is estimated.During processing of this complaint, attempts were made to obtain complete event information and device information.The unique device identifier (udi #) is unknown.

Event Description

Related manufacturer reference number: 1627487-2021-18937.It was reported that the lead site wound had fluid discharge.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.

Event Description

Additional information was received that the issue resolved without sequelae.

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.Additional information: section d: certain fields have been updated or entered based on new information.G3 - pma/510(k) #: field has been updated based on new information.H4: date has been entered based on new information.

Event Description

Additional related manufacturer reference numbers: 1627487-2022-00824, 1627487-2022-00825.Additional information was received about the original issue that the patient had an allergic reaction on the skin of the forehead and around the cranial wound.

• Brand Name: DBS LEAD
• Type of Device: 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: 13041249
• MDR Text Key: 282484862
• Report Number: 1627487-2021-18936
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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 Operator: Health Professional
• Device Expiration Date: 06/27/2022
• Device Model 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
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/13/2022; 02/07/2022
• Supplement Dates FDA Received: 02/01/2022; 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization