MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B; DBS EXTENSION

Model Number 6372

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer report number: 1627487-2020-30846, 1627487-2020-30850, 1627487-2020-30851.It was reported that during an unrelated ipg replacement procedure (manufacturer report number 1627487-2020-30843), high impedances were observed due to inability to place the leads extensions successfully.Low impedances on one lead were also observed.The leads were not replaced during the procedure and remain implanted, but the patient may undergo additional surgical intervention to address 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): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10491097
• MDR Text Key: 205594461
• Report Number: 1627487-2020-30847
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 6372
• Device Catalogue Number: 6372
• Device Lot Number: 6469373
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DBS LEAD (X2); DBS LEAD EXTENSION; DBS LEAD (X2); DBS LEAD EXTENSION
• Patient Outcome(s): Other
• Patient Weight: 104