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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, NEUROMODULATION OCTRODE; OCTRODE TRIAL KIT
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ST. JUDE MEDICAL, NEUROMODULATION OCTRODE; OCTRODE TRIAL KIT Back to Search Results
Model Number 3086
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 01/10/2014
Event Type  Injury  
Event Description
The patient had two leads implanted with the same lot number.It was reported the patient's trial leads were pulled due to an allergic response to the tape.Patient experienced itching and redness at the tape site.The patient is still healing.
 
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Brand Name
OCTRODE
Type of Device
OCTRODE TRIAL KIT
Manufacturer (Section D)
ST. JUDE MEDICAL, NEUROMODULATION
plano TX
Manufacturer Contact
tanja hoffman
6901 preston rd.
plano, TX 75024
9723098520
MDR Report Key3641935
MDR Text Key4280913
Report Number1627487-2014-26088
Device Sequence Number1
Product Code GZB
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
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2015
Device Model Number3086
Device Lot Number4285089
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/13/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
IMPLANT DATE:; SCS LEAD, MODEL 3244; SCS LEAD, MODEL 3288; SCS LEAD, MODEL 3219; SCS IPG, MODEL 3788; IMPLANT DATE:
Patient Outcome(s) Other;
Patient Age42 YR
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