MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B

Model Number 6173

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Incontinence (1928)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Further information was requested but not received.During processing of this incident, attempts were made to obtain complete patient information.The results/ method and conclusion codes along with investigation results will be provided on the final report.

Event Description

Related manufacturer report : 1627487-2020-30570.It was reported that patient experience severe side effects such as incontinence episodes however it is unknown how long this has been going on for.The device system was turned off.Patient requested to be seen in another territory and the device system was explanted at an unknown date.No further information is available at this time.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B
• Type of Device: DBS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10447688
• MDR Text Key: 204177985
• Report Number: 1627487-2020-30571
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030337
• UDI-Public: 05415067030337
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: 6173
• Device Catalogue Number: 6173
• Device Lot Number: 6848334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DBS LEAD; DBS LEAD
• Patient Outcome(s): Other