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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

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD Back to Search Results
Model Number 3186
Device Problem High impedance (1291)
Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  Injury  
Manufacturer Narrative
Date of event estimated.
 
Event Description
It was reported one lead has high impedance preventing the patient from entering mri mode. In turn, surgical intervention may take place in the future. Both of the patient's leads are being reported because it's unknown which one of the leads has high impedance.
 
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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 Key12233330
MDR Text Key263830621
Report Number3006705815-2021-03655
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/25/2020
Device Model Number3186
Device Catalogue Number3186
Device Lot NumberA000050928
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 Received09/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2018
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: 07/27/2021 Patient Sequence Number: 1
Treatment
3186 SCS LEAD
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