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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION INFINITY¿ 5 IPG; DBS IPG

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ST. JUDE MEDICAL - NEUROMODULATION INFINITY¿ 5 IPG; DBS IPG Back to Search Results
Model Number 6660
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Inadequate Pain Relief (2388)
Event Date 04/29/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.
 
Event Description
It was reported the patient underwent an unrelated surgical procedure on (b)(6) 2019.Since the procedure, the patient's ipg has been unable to communicate with their external device due to it being inoperable.Troubleshooting attempts have been unable to provide resolution.As a result, the patient will undergo surgical intervention.
 
Event Description
Further follow-up indicates the patient had surgical intervention on (b)(6)2019, during which the ipg was explanted and replaced.The issue was resolved and therapy has been restored.
 
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Brand Name
INFINITY¿ 5 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 Key8621902
MDR Text Key145472022
Report Number1627487-2019-05840
Device Sequence Number1
Product Code MHY
UDI-Device Identifier05415067020246
UDI-Public05415067020246
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
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 10/24/2019
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 Date03/19/2020
Device Model Number6660
Device Lot Number6357887
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/29/2019
Initial Date FDA Received05/17/2019
Supplement Dates Manufacturer Received07/08/2019
10/17/2019
Supplement Dates FDA Received07/12/2019
10/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/06/02/2017/001-C
Patient Sequence Number1
Patient Outcome(s) Other;
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