• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM SCS PADDLE LEAD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM SCS PADDLE LEAD Back to Search Results
Model Number 3228
Device Problem Disconnection (1171)
Patient Problem Inadequate Pain Relief (2388)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated. 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 Description

Related manufacturer reference number: 1627487-2020-04094. It was reported that patient lost therapy. Imaging indicated that the lead had pulled out of the ipg header. As a result, patient underwent surgical intervention wherein the ipg and lead were explanted.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePENTA 3MM LEAD, 60 CM
Type of DeviceSCS PADDLE LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10020006
MDR Text Key189692345
Report Number1627487-2020-04093
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 05/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/28/2015
Device MODEL Number3228
Device Catalogue Number3228
Device LOT Number4287034
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/10/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/04/2020 Patient Sequence Number: 1
Treatment
SCS IPG
-
-