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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION 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 Problems Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported the patient placed their device into mri mode approximately one year ago and the device was never taken out of mri mode.Abbott representative tried to connect to the ipg to no avail.Patient does not know her credentials.Surgical intervention may take place at a later date.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete patient information.
 
Event Description
Additional information received indicates the ipg was explanted and replaced.Therapy was restored.
 
Manufacturer Narrative
Based on information obtained the device is included in the neuromodulation implantable pulse generator (ipg) unable to exit mri mode advisory notice issued by abbott on 22 june 2023.Fsca number is pending.
 
Event Description
Based on information obtained the device is included in the neuromodulation implantable pulse generator (ipg) unable to exit mri mode advisory notice issued by abbott on 22 june 2023.Fsca number is pending.
 
Manufacturer Narrative
The fsca number is included in this report.A patient unable to disable mri mode and activate therapy was reported to abbott.Troubleshooting steps did not resolve the issue.The ipg was replaced to reestablish therapy.Based on the information received, the event is consistent with the loss of the bluetooth pairing bond while in mri mode.As a result of this finding, abbott is performing further investigation.
 
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Brand Name
PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
Type of Device
SCS 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
Manufacturer Contact
heidi syndergaard
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10525183
MDR Text Key206712777
Report Number1627487-2020-31364
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067020192
UDI-Public05415067020192
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 Consumer,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/31/2023
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 Date06/21/2019
Device Model Number3660
Device Catalogue Number3660
Device Lot Number6011904
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/27/2020
Initial Date FDA Received09/11/2020
Supplement Dates Manufacturer Received11/02/2020
11/30/2020
06/22/2023
10/24/2023
Supplement Dates FDA Received11/21/2020
12/01/2020
07/19/2023
10/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1627487-07/07/2023-001-C
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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