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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 SCS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD Back to Search Results
Model Number 3186
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Respiratory Distress (2045)
Event Date 10/23/2020
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: 3006705815-2020-32610. It was reported that during an implant procedure on (b)(6) 2020, after the first incision but before any device had been implanted, the patient experienced breathing difficulty. The physician flipped the patient to resume regular breathing. The procedure was completed following this event.

 
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Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Type of DeviceSCS 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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10833916
MDR Text Key216094013
Report Number3006705815-2020-32611
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
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 12/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3186
Device Catalogue Number3186
Device LOT NumberA000096320
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 Received11/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/21/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 11/12/2020 Patient Sequence Number: 1
Treatment
SCS LEAD
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