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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTEGE IPG, 16-CHANNEL RECHARGEABLE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTEGE IPG, 16-CHANNEL RECHARGEABLE SCS IPG Back to Search Results
Model Number 3789
Device Problems Device Stops Intermittently (1599); Low impedance (2285)
Patient Problems Fall (1848); Inadequate Pain Relief (2388)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
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
Device 1 of 3. Reference mfr report: 1627487-2017-02803 and 1627487-2017-02804. It was reported the patient experienced a fall and the patient's scs stimulation was turning on and off since. A company representative met with the patient and troubleshooting of the patient¿s system revealed low impedance for all of the leads contacts. Follow up identified surgical intervention was taken, during the procedure the physician suspected fluid may have entered into the ipg header. In addition, the patient's ipg was inoperable, the physician replaced the ipg. Reportedly, stimulation therapy was restored postoperatively.
 
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Brand NamePROTEGE IPG, 16-CHANNEL RECHARGEABLE
Type of DeviceSCS 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
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
arnie ochoa
6901 preston road
plano, TX 75024
9723098090
MDR Report Key6590486
MDR Text Key75960473
Report Number3006705815-2017-00578
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 05/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2016
Device Model Number3789
Device Lot Number4841050
Other Device ID Number05414734405690
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2014
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: 05/25/2017 Patient Sequence Number: 1
Treatment
MODEL 1192 (X2), SCS ANCHOR
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