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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS TRIAL LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS TRIAL LEAD Back to Search Results
Model Number 3086
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/27/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 3006705815-2020-31307.It was reported that patient experienced abnormal bleeding during a trial procedure.The physician held the incision and applied pressure for 15 minutes.Reportedly, patient had stopped taking blood thinners prior to the procedure.The issue was resolved.
 
Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
 
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Brand Name
OCTRODE TRIAL LEAD KIT, 60CM LENGTH
Type of Device
SCS TRIAL 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
MDR Report Key10518660
MDR Text Key206486512
Report Number3006705815-2020-31308
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734401555
UDI-Public05414734401555
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/07/2022
Device Model Number3086
Device Catalogue Number3086
Device Lot NumberA000095864
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/27/2020
Initial Date FDA Received09/10/2020
Supplement Dates Manufacturer Received10/09/2020
Supplement Dates FDA Received10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODEL 3086, SCS LEAD
Patient Outcome(s) Other;
Patient Weight73
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