MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B; DBS EXTENSION

Model Number 6371

Device Problem High impedance (1291)

Patient Problems Twiddlers Syndrome (4563); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer report number: 1627487-2021-16803, 1627487-2021-16804.It was reported that high impedances were observed.As a result, the patient underwent surgical intervention during which the patient's ipg and extensions were 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.

Event Description

Additional information received indicates that the patient's extension were twisted.The issue was confirmed via x-ray and the patient was suspected of twiddling.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B
• Type of Device: DBS EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12433839
• MDR Text Key: 270129936
• Report Number: 1627487-2021-16805
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020307
• UDI-Public: 05415067020307
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2021
• Device Model Number: 6371
• Device Catalogue Number: 6371
• Device Lot Number: 6793975
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 09/09/2021; 09/29/2021
• Supplement Dates FDA Received: 09/16/2021; 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DBS IPG.; DBS LEAD EXTENSION.; DBS IPG; DBS LEAD EXTENSION
• Patient Outcome(s): Other
• Patient Weight: 77