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

Model Number 6372

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Therapeutic Response, Decreased (2271); Inadequate Pain Relief (2388)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.

Event Description

It was reported the patient went to the hospital because she felt her symptoms worsening.Upon evaluation of the patient's dbs system by the neurologist, the impedance measured high on the system.Consequently, surgical intervention was taken, during the procedure the neurosurgeon disconnected the extensions from the implantable pulse generator (ipg), after the extension was checked it showed high impedance on all contacts.The neurosurgeon disconnected the lead from the extension and measured the impedance of the lead.Multiple lead contacts showed high impedance, but the patient could be stimulated through the contacts.Based on the current going through the contacts the neurosurgeon decided to replace the lead extension with a new one, and the issue was addressed.

Manufacturer Narrative

The return flex lead extension had all contacts wires broken along the lead body.The cause of the reported event is consistent with an overstress condition or sudden event the lead was subjected while in vivo.

• 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
• MDR Report Key: 10781897
• MDR Text Key: 214521843
• Report Number: 1627487-2020-33206
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030351
• UDI-Public: 05415067030351
• Combination Product (y/n): N
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2021
• Device Model Number: 6372
• Device Catalogue Number: 6372
• Device Lot Number: 7112860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other