MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B

Model Number 6173

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/19/2023

Event Type  Injury  

Manufacturer Narrative

Event date is estimated.The event of a full system explant was reported to abbott.The leads had not been placed in the correct location.The procedure was completed without complications.The device was not returned for evaluation.Based on the information received, the cause of the reported issue was determined not to be product related.

Event Description

Related manufacturer report number:1627487-2023-02182.It was reported that the patient was not receiving adequate therapy.Surgical intervention was undertaken on (b)(6) 2023, wherein the patient's dbs system was explanted.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B
• 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: 16906327
• MDR Text Key: 314946130
• Report Number: 1627487-2023-02181
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020697
• UDI-Public: 05415067020697
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2018
• Device Model Number: 6173
• Device Catalogue Number: 6173
• Device Lot Number: 5664460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2016
• 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
• Treatment: DBS IPG.; DBS LEAD EXTENSION (X2).
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 79 KG