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

Model Number 6372

Device Problem Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

¿date of event¿ is estimated.During processing of this complaint, attempts were made to obtain patient weight.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the right-side extension had a torn outer layer.Surgery occurred to explant and replace the extension to address the issue.

Manufacturer Narrative

The reported event, of lead extension damaged was confirmed.As received, a kink with no broken wires was observed, as well as broken nitinol at terminal end.Lead extension passed electrical (impedance and continuity) testing.The root cause is consistent with an overstress condition or sudden event, that the extension was subjected to while still 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: 11128565
• MDR Text Key: 225486019
• Report Number: 1627487-2021-00007
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020857
• UDI-Public: 05415067020857
• 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: 01/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2019
• Device Model Number: 6372
• Device Catalogue Number: 6372
• Device Lot Number: 5981544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other