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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 Problems Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burning Sensation (2146); Discomfort (2330)
Event Date 06/07/2021
Event Type  Injury  
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.
 
Event Description
Related manufacturer reference number: 3006705815-2021-03107, 3006705815-2021-03109. It was reported that patient experienced burning sensation at the implant site during an mri procedure. The device was placed on the mri mode. As a result, the mri was abandoned. The patient is stable post procedure.
 
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Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Type of DevicePERCUTANEOUS 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
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key12068521
MDR Text Key258402336
Report Number3006705815-2021-03108
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
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 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3186
Device Catalogue Number3186
Device Lot NumberA000092984
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 Received06/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/25/2021 Patient Sequence Number: 1
Treatment
PERCUTANEOUS LEAD; SCS IPG
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