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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; PERCUTANEOUS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD Back to Search Results
Model Number 3186
Device Problem High impedance (1291)
Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 11/06/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.Further information was requested but not received.
 
Event Description
Related manufacturer reference number: 3006705815-2021-04628.It was reported the patient experienced autoreducing causing ineffective stimulation.Diagnostics indicated high impedances.In turn, the system was explanted and replaced to address the issue.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand Name
OCTRODE LEAD KIT, 60CM LENGTH
Type of Device
PERCUTANEOUS 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 Key12488558
MDR Text Key271918393
Report Number3006705815-2021-04629
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,health
Type of Report Initial,Followup
Report Date 09/27/2021
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? Yes
Device Operator Health Professional
Device Expiration Date08/16/2020
Device Model Number3186
Device Catalogue Number3186
Device Lot NumberA000063927
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/30/2021
Initial Date FDA Received09/17/2021
Supplement Dates Manufacturer Received09/24/2021
Supplement Dates FDA Received09/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PERCUTANEOUS LEAD; PERCUTANEOUS LEAD
Patient Outcome(s) Other;
Patient Age45 YR
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