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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM TM 5 ELITE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM TM 5 ELITE SCS IPG Back to Search Results
Model Number 3660
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Inflammation (1932); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing. Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Sjm defers to the patient's physician regarding medical history.
 
Event Description
The patient has multiple scs systems implanted and this report is related to the scs system implanted on (b)(6) 2016. It was reported that the patient experienced swelling and inflammation at the ipg site. The patient was given prophylactic antibiotics, although the surgeon confirmed that their was no infection. Patient underwent surgical intervention on (b)(6) 2017 to have their ipg pocket cleaned out and revised.
 
Event Description
Follow up revealed that the patients ipg was explanted (reference mfr report 1627487-2017-01965). The patient's pain has been resolved.
 
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Brand NamePROCLAIM TM 5 ELITE
Type of DeviceSCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key6449664
MDR Text Key71388097
Report Number1627487-2017-01548
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/19/2018
Device Model Number3660
Device Lot Number5606907
Other Device ID Number05415067020192
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2016
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: 03/31/2017 Patient Sequence Number: 1
Treatment
MODEL: 3228, SCS LEAD; MODEL: 3383, SCS EXTENSION (2)
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