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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 Problems Fever (1858); Pain (1994); Swelling/ Edema (4577)
Event Date 01/11/2021
Event Type  Injury  
Event Description
It was reported the patient was experiencing pain and swelling at the ipg site.Patient also reported a fever with sweats.The physician stated the patient had cellulitis.As a result, the patient underwent surgical intervention during which the system was explanted with no complications.
 
Event Description
Related manufacturer report number: 3006705815-2021-00557, 3006705815-2021-00558, 1627487-2021-01174, 1627487-2021-01176.
 
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.Correction: section g2 - report source should have checked off health professional instead of user facility.This correction is reflected in this additional report 1.
 
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Brand Name
PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
Type of Device
SCS 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
MDR Report Key11256573
MDR Text Key229577921
Report Number3006705815-2021-00350
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067031419
UDI-Public05415067031419
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/27/2022
Device Model Number3660
Device Catalogue Number3660
Device Lot NumberA000097667
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/14/2021
Initial Date FDA Received01/31/2021
Supplement Dates Manufacturer Received02/01/2021
Supplement Dates FDA Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS LEAD (X2).; SCS LEAD ANCHOR (X2).
Patient Outcome(s) Other;
Patient Weight73
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