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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 Wound Dehiscence (1154)
Event Date 02/11/2021
Event Type  Injury  
Manufacturer Narrative
The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to the implanted system.
 
Event Description
Related mfr report: 1627487-2021-01588. It was reported the patient's implantable pulse generator (ipg) surgical incision opened and the generator was protruding through their skin. Reportedly, the issue occurred after a weight loss of 50-60 pounds. Surgical intervention was taken and the patient's ipg and lead were removed. A new lead was placed at this time and a new ipg will be placed in a couple months, once any possible infection has been treated and the wound has healed. There were no issues during the procedure.
 
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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 Key11369636
MDR Text Key233253865
Report Number3006705815-2021-00804
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,health
Reporter Occupation
Type of Report Initial
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/11/2021
Device Model Number3660
Device Catalogue Number3660
Device Lot NumberA000078748
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 Received02/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2019
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: 02/23/2021 Patient Sequence Number: 1
Treatment
MODEL 3219, SCS LEAD
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