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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: 3006705815-2020-32611.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.
 
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 LEAD KIT, 60CM LENGTH
Type of Device
SCS 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 Key10833914
MDR Text Key216093643
Report Number3006705815-2020-32610
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067017246
UDI-Public05415067017246
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,consum
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 Expiration Date04/21/2022
Device Model Number3186
Device Catalogue Number3186
Device Lot NumberA000096320
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS LEAD; SCS LEAD
Patient Outcome(s) Other;
Patient Weight137
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