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 Twiddlers Syndrome (4563)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.

Event Description

Related manufacturer report number 1627487-2021-17972.It was reported that the patient has twiddler's syndrome, and was twiddling their ipg, breaking the extension cable and causing high impedance.In turn, surgical intervention was undertaken wherein the extension was explanted and replaced, resolving the issue.

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.

• 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: 12707588
• MDR Text Key: 278667320
• Report Number: 1627487-2021-17973
• Device Sequence Number: 1
• Product Code: MHY
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6372
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6372, DBS EXTENSION; 6372, DBS EXTENSION
• Patient Outcome(s): Other