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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 Problems Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/25/2021
Event Type  Injury  
Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.

 
Event Description

It was reported the patient's ipg became inoperable following an unrelated surgery. Surgical intervention may be taken at a later date to address the issue.

 
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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 Key12180945
MDR Text Key261945896
Report Number3006705815-2021-03408
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 09/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3660
Device Catalogue Number3660
Device LOT NumberA000091982
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 Received09/08/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/08/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/06/02/2017/001-C

Patient TREATMENT DATA
Date Received: 07/16/2021 Patient Sequence Number: 1
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