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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 Problems Fracture (1260); Impedance Problem (2950)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/20/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.
 
Event Description
Related manufacturer report number: 3006705815-2021-04414. It was reported the patient was experiencing ineffective therapy. It was noted that one lead had fractured and invalid impedances. As a result, the patient underwent surgical intervention during the lead was supposed to be replaced, but during the procedure the lead anchors were scarred together so the physician explanted and replaced both leads. Therapy was turned on post-procedure.
 
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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 Key12435996
MDR Text Key270275500
Report Number3006705815-2021-04413
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3186
Device Catalogue Number3186
Device Lot NumberA000097301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2020
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: 09/07/2021 Patient Sequence Number: 1
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