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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 Temperature Problem (3022)
Patient Problem Burning Sensation (2146)
Event Date 06/30/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.
 
Event Description
It was reported that the patient experienced a burning sensation at the ipg pocket site.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced.Post-operatively, the issue resolved and stimulation therapy was restored.
 
Manufacturer Narrative
The reported wound issue and pocket heating were not confirmed.The wound issue could not be confirmed with product testing.As received, normal pairing and bluetooth (ble) communication was observed.The uep inductive tool showed it was running the therapy application which is a normal indication.To address the pocket heating issue, the field scenario was recreated by attaching the ipg to a load block, placing in a heated chamber and turning on stimulation.After 3 hours, the temperature of the ipg increased by 0.4°c degrees.As the rise in temperature was less than 2 degrees, it met the product specification for heat generation during use.The ipg was tested to manufacturing specifications using the auto tester and passed all tests.No physical or functional anomaly was identified during analysis that would contribute to the reported issue was observed.
 
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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 Key12194338
MDR Text Key262408355
Report Number3006705815-2021-03538
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 10/22/2021
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? Yes
Device Operator Health Professional
Device Expiration Date02/17/2022
Device Model Number3660
Device Catalogue Number3660
Device Lot NumberA000093870
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/30/2021
Initial Date FDA Received07/20/2021
Supplement Dates Manufacturer Received10/19/2021
Supplement Dates FDA Received10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight112
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