MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B; DBS EXTENSION

Model Number 6372

Device Problem High impedance (1291)

Patient Problems Failure of Implant (1924); Movement Disorder (4412)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

B3-date of event is estimated.

Event Description

Related manufacturer reference number 1627487-2024-00457.It was reported that patient experienced ineffective therapy.System diagnostics recorded high impedances on both extensions.As a result, surgical intervention was undertaken wherein the extensions were explanted and replaced.Effective therapy was restored post operatively.

Manufacturer Narrative

Corrected data: b.Adverse event or product problem.D10 - concomitant medical products and therapy dates.H6 - adverse event problem (refer to coding manual).

Manufacturer Narrative

"the report of high impedance was confirmed.Analysis of extension b found it had all internal wires broken in the lead body near the terminal end (see images).These fractures are consistent with an overstress condition or sudden event the lead was subjected to while still in vivo.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.".

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 60CM, 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18584652
• MDR Text Key: 333772577
• Report Number: 1627487-2024-00458
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030351
• UDI-Public: 05415067030351
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: 6372
• Device Lot Number: 7776417
• 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: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• 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
• Treatment: DBS IPG
• Patient Outcome(s): Other