MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 22CM BIG CURVE DELIVERY SHEATH KIT; DRG SHEATH

Model Number	MN13650
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure to place drg trial leads, the tip of the sheath appeared to have been sheared off and remained inside the patient.There were no consequences to the patient.No intervention to retrieve the device is planned at this time.

• Brand Name: 22CM BIG CURVE DELIVERY SHEATH KIT
• Common Device Name: DRG SHEATH
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8170336
• Report Number: 1627487-2018-13082
• Device Sequence Number: 1684427
• Product Code: PMP
• UDI-Device Identifier: 05415067027207
• UDI-Public: 05415067027207
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2019
• Device Model Number: MN13650
• Device Catalogue Number: MN13650
• Device Lot Number: AB2456
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68