MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION KIT LEAD EXTENSION, 50CM; DRG EXTENSION

Model Number	MN10550-50
Medical Device Problem Codes	Therapeutic or Diagnostic Output Failure (3023); Insufficient Device Problem Information (3190); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference# 1627487-2019-13513, 1627487-2019-13514, 1627487-2019-13516 & 1627487-2019-13515.It was reported the patient's drg system will be explanted.The exact explant date and reason is unknown.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Further follow-up indicates the patient had surgical intervention on (b)(6) 2019, during which the system was explanted due to the ipg inoperable.
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
Further follow-up indicates therapy was ineffective.

• Brand Name: KIT LEAD EXTENSION, 50CM
• Common Device Name: DRG EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9412220
• Report Number: 1627487-2019-13521
• Device Sequence Number: 4202563
• Product Code: PMP
• UDI-Device Identifier: 05415067025562
• UDI-Public: 05415067025562
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2018
• Device Model Number: MN10550-50
• Device Catalogue Number: MN10550-50
• Device Lot Number: AB2089
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 12/19/2019; 01/15/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/10/2020; 01/21/2020
• 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: DRG IPG; DRG LEAD (3)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Weight: 79