MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B

Model Number	6170
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided on the final report.During processing of this incident, attempts were made to obtain complete device information.Date of the event is estimated.
Event or Problem Description
Related manufacturer report number 1627487-2020-22934.It was reported that during a lead explant procedure, physician was unable to explant the entire lead and a partial of the lead remains subcutaneously implanted in the brain tissue.It is unknown which lead had the issue therefore both leads are being reported.A new lead was successfully implanted.Patient was stable.
Additional Manufacturer Narrative
The allegation that part of the lead remained implanted in the patient was not confirmed.This issue cannot be confirmed with product testing.The lead was returned cut and incomplete and could not be fully analyzed.Ten cm of the middle segment was missing.Per the event details, the lead had to be cut while attempting to explant it, due to part of it being firmly secured by scar tissue on the skull.Visual inspection did not identify any anomaly or damage that existed prior to explant.The root cause of the issue could not be definitively determined.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B
• Common Device Name: DBS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10292307
• Report Number: 1627487-2020-22589
• Device Sequence Number: 11030999
• Product Code: MHY
• UDI-Device Identifier: 05415067020642
• UDI-Public: 05415067020642
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2021
• Device Model Number: 6170
• Device Catalogue Number: 6178
• Device Lot Number: 6848323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/27/2020; 09/24/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/13/2020; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DBS LEAD
• Outcome Attributed to Adverse Event: Other