• 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 (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS 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 (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD Back to Search Results
Model Number 3186
Device Problems Low impedance (2285); Impedance Problem (2950)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2018
Event Type  Injury  
Event Description

Related manufacturer reference number: 3006705815-2021-03668, 3006705815-2021-03696. It was reported the patient was experiencing invalid impedances. In turn, the ipg was unable to enter mri mode. Troubleshooting performed but was unsuccessful. Surgical intervention may occur later to address the issue.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Type of DevicePERCUTANEOUS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key12315769
MDR Text Key266296287
Report Number3006705815-2021-03689
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/01/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/07/2019
Device MODEL Number3186
Device Catalogue Number3186
Device LOT NumberA000038593
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 Received08/31/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/07/2017
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: 08/12/2021 Patient Sequence Number: 1
Treatment
PERCUTANEOUS LEAD (X1)SCS IPG
-
-