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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 50CM LEAD EXTENSION KIT; DRG EXTENSION
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ST. JUDE MEDICAL - NEUROMODULATION 50CM LEAD EXTENSION KIT; DRG EXTENSION Back to Search Results
Model Number MN10550-50
Medical Device Problem Code Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 10/29/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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
Reference mfr.Report#: 1627487-2019-12446, 1627487-2019-12449, 1627487-2019-12521, 1627487-2019-12522.It was reported that the patient was experiencing ineffective stimulation.As a result, surgical intervention took place wherein the patient had their entire system explanted.The exact date of explant is unknown.
 
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Brand Name
50CM LEAD EXTENSION KIT
Common Device Name
DRG EXTENSION
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key9293739
Report Number1627487-2019-12448
Device Sequence Number2311093
Product Code PMP
UDI-Device Identifier05415067025562
UDI-Public05415067025562
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
P150004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/07/2019
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 Date07/24/2019
Device Model NumberMN10550-50
Device Catalogue NumberMN10550-50
Device Lot NumberAB2384
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 10/29/2019
Initial Report FDA Received Date11/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
DRG EXTENSION; DRG IPG; DRG LEAD X 2
Outcome Attributed to Adverse Event Other;
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