MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LEAD EXTENSION KIT; DRG ADAPTER

Model Number	MN10550-50
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
Event or Problem Description
Device 1 of 2.Reference mfr report: 1627487-2018-07480.It was reported during the patient's permanent drg system implant procedure after the trial, the physician experienced difficulty removing one of the trial extensions.Reportedly, the physician had a difficult time backing out the set screw for one of the extensions, the screw was able to torque down, but not back out.The physician used a hex wrench and he was able to unlock the extension, and both extensions were removed.The procedure was completed and no further intervention was necessary.

• Brand Name: LEAD EXTENSION KIT
• Common Device Name: DRG ADAPTER
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7774282
• Report Number: 1627487-2018-07479
• Device Sequence Number: 13706263
• Product Code: PMP
• UDI-Device Identifier: 05415067025562
• UDI-Public: 05415067025562
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/10/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: MN10550-50
• Device Catalogue Number: MN10550-50
• Device Lot Number: AB2173
• 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: 07/16/2018
• Initial Report FDA Received Date: 08/10/2018
• 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: MODEL MN10450-50A (X2), DRG LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR