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

Model Number 6371

Device Problem Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Date of event: event date is estimated.Implant date is unknown.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: dbs extension lead, model: 6373, udi: (b)(4).

Event Description

It was reported that the patient is experiencing ineffective stimulation.The investigation did not determine which extension has caused this issue.Surgical intervention is pending.

Manufacturer Narrative

Correction d4- device information is updated.Conclusion: the report event of impedance issue was not confirmed.As received, visual inspection and resistance testing showed the returned lead extension (a) passed the functional test.The cause of the reported event remains unknown.

Event Description

Additional information received reports that the patient underwent surgical intervention on (b)(6)2023 in which the extension was explanted and replaced.

• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16024613
• MDR Text Key: 305912934
• Report Number: 1627487-2022-06927
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030344
• UDI-Public: 05415067030344
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6371
• Device Catalogue Number: 6372
• 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: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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