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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD Back to Search Results
Model Number 3186
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Coma (2417); Post Operative Wound Infection (2446)
Event Date 05/12/2017
Event Type  Injury  
Manufacturer Narrative
The reported event cannot be analyzed via laboratory testing.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
 
Event Description
Device 1 of 4.Reference mfr report#1627487-2017-03085.Reference mfr report#1627487-2017-03086.Reference mfr report#1627487-2017-03087.The patient received two extensions with the same lot number.It was reported during permanent implant ((b)(6)) a hematoma was observed at the lead and extension site.Reportedly, the patient was unresponsive after the procedure.Due to infection concern, the scs system was explanted on (b)(6) 2017.Follow-up identified the patient will continue evaluation to confirm the issue.
 
Event Description
Device 1 of 4.Reference mfr report#1627487-2017-03085, reference mfr report#1627487-2017-03086, reference mfr report#1627487-2017-03087.Follow-up identified the patient recently expired due to an unrelated issue.The date of death is unknown.
 
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Brand Name
OCTRODE LEAD KIT, 60CM LENGTH
Type of Device
SCS 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
MDR Report Key6633624
MDR Text Key77318294
Report Number1627487-2017-03106
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/18/2019
Device Model Number3186
Device Lot Number5809260
Other Device ID Number05414734401708
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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