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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG Back to Search Results
Model Number 3660
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description
It was reported the patient experienced a pocket infection. As a result, surgical intervention took place wherein the ipg was explanted to address the issue.
 
Manufacturer Narrative
Date of event is estimated.
 
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Brand NamePROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
Type of DeviceSCS IPG
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 Key15171918
MDR Text Key297311483
Report Number3006705815-2022-15933
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067031419
UDI-Public05415067031419
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3660
Device Catalogue Number3660
Device Lot NumberA000122194
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2022
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: 08/04/2022 Patient Sequence Number: 1
Treatment
SCS LEAD
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