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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PENTA 3MM LEAD, 60 CM SCS PADDLE LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PENTA 3MM LEAD, 60 CM SCS PADDLE LEAD Back to Search Results
Model Number 3228
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Paralysis (1997)
Event Date 09/13/2021
Event Type  Injury  
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 event could not be conclusively determined.
 
Event Description
It was reported the patient experienced paralysis following a permanent implant procedure on (b)(6) 2021. As a result, surgical intervention was undertaken on (b)(6) 2021, wherein the paddle lead was removed from the epidural space and placed in the fascia. Later, the patient underwent additional intervention on (b)(6) 2021 wherein the paddle lead was explanted and replaced for two percutaneous leads to further address the issue.
 
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Brand NamePENTA 3MM LEAD, 60 CM
Type of DeviceSCS PADDLE 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 Key12548501
MDR Text Key273990447
Report Number3006705815-2021-04642
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067017253
UDI-Public05415067017253
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
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3228
Device Catalogue Number3228
Device Lot NumberA000109239
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 Received09/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/2021
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: 09/29/2021 Patient Sequence Number: 1
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