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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION INFINITY IPG; DBS IPG

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ST. JUDE MEDICAL - NEUROMODULATION INFINITY IPG; DBS IPG Back to Search Results
Model Number 6662
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/15/2019
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that the patient external devices were not connecting to the ipg.The patient had an unrelated surgery on (b)(6) 2019 and surgery mode was used.Troubleshooting was done and the ipg was able to be recovered.
 
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Brand Name
INFINITY IPG
Type of Device
DBS 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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8853373
MDR Text Key153090573
Report Number1627487-2019-08653
Device Sequence Number1
Product Code MHY
UDI-Device Identifier05415067020260
UDI-Public05415067020260
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2021
Device Model Number6662
Device Lot Number6926008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/16/2019
Initial Date FDA Received08/01/2019
Supplement Dates Manufacturer Received08/28/2019
Supplement Dates FDA Received08/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Weight75
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