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

Model Number 6372

Device Problem Fracture (1260)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer report number 1627487-2022-02904.It was reported that the patient was experiencing a shocking sensation.It was found that both of the extensions were broken.In turn, surgical intervention was undertaken wherein the extensions were explanted and replaced, resolving the issue.

Manufacturer Narrative

The report of ¿fractured extension¿ was confirmed.Analysis of the returned lead extension a found multiple fractured internal wires.The fractures are consistent with an overstress condition or sudden event the extension was subjected to while still in vivo.The fractures being in close proximity would cause intermittent stimulation which could be misinterpreted as a ¿shocking¿ sensation.

• 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: 14458648
• MDR Text Key: 292192533
• Report Number: 1627487-2022-02903
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030351
• UDI-Public: 05415067030351
• 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
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: 6372
• Device Catalogue Number: 6372
• Device Lot Number: 7389918
• 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: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• 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; DBS LEAD (2)
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 68 KG