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

Model Number	MN10550-50
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results will be provided in the final report.
Event or Problem Description
Manufacturer report number 1627487-2020-01902.It was reported that one of the patient's existing lead extensions would not lock to an existing drg lead during a pocket revision on (b)(6) 2020 (reference reg report: 1627487-2020-01555).In turn, the existing lead extension was explanted and replaced to address the issue.It is unknown which lead extension is related to the issue.Therefore, all the suspected devices are being reported.
Additional Manufacturer Narrative
As received, the returned lead extension set screw was found stuck against the retaining washer in the connector assembly due to over-torque condition.The cause of the event is consistent with damage during use.There is adequate information in the clinician's manual that addresses proper loosening and tightening of the set screw.

• Brand Name: KIT LEAD EXTENSION, 50CM
• Common Device Name: DRG LEAD EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9741036
• Report Number: 1627487-2020-01899
• Device Sequence Number: 11256372
• Product Code: PMP
• UDI-Device Identifier: 05415067025562
• UDI-Public: 05415067025562
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 07/13/2019
• Device Model Number: MN10550-50
• Device Catalogue Number: MN10550-50
• Device Lot Number: AB2369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other