MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B; DBS EXTENSION

Model Number 6371

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/24/2021

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2021-19425.Related manufacturer reference number: 1627487-2021-19427.It was reported that the patient experienced ineffective therapy.Diagnostics revealed that the impedances were in normal range but on the lower side.Preprogramming was unable to resolve the issue.As such, surgical intervention took place on (b)(6) 2021 wherein the ipg and right extension was explanted and replaced to address the issue.However, the effective therapy was not achieved.Ct scan revealed that the lead had migrated.As such, additional surgical intervention took place on (b)(6) 2021 where in the right lead was explanted and replaced with a new lead addressing the issue.Reportedly, patient is receiving effective therapy post operatively.

Manufacturer Narrative

Date of event is estimated.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

The report of ineffective stimulation was not confirmed.Analysis of the returned lead extension found it had no physical anomalies, it passed output resistance, and inter-channel continuity testing.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B
• Type of Device: DBS EXTENSION
• 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: 13114882
• MDR Text Key: 282961235
• Report Number: 1627487-2021-19426
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030344
• UDI-Public: 05415067030344
• 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,Followup,Followup,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: 6371
• Device Catalogue Number: 6371
• Device Lot Number: 7917599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• 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 EXTENSION; DBS LEAD
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 73 KG