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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE SCS IPG Back to Search Results
Model Number 3662
Device Problem Device Inoperable (1663)
Patient Problem Inadequate Pain Relief (2388)
Event Date 04/10/2018
Event Type  Injury  
Manufacturer Narrative
The manufacturer 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. The manufacturer defers to the patient's physician regarding medical history.
 
Event Description
It was reported the patient underwent an unrelated surgical procedure on (b)(6) 2018. The patient was unable to connect the ipg with any other devices postoperatively, and the clinical programmer displayed the error message, ¿a problem was found with the generator that could not be repaired. ¿ troubleshooting attempts have been unsuccessful, and the ipg has been deemed inoperable. As a result, the patient may be awaiting surgical intervention to explant and replace the ipg.
 
Manufacturer Narrative
The capa was initiated on (b)(6) 2016 to address the issue of the proclaim ipg entering service application. Investigation is complete and being monitored by the manufacturer.
 
Event Description
Follow up information identified the physician explanted and replaced the patient¿s ipg. Additionally, it was learned electrocautery was utilized during the surgery on (b)(6) 2018.
 
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Brand NamePROCLAIM 7 ELITE
Type of DeviceSCS 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
MDR Report Key7548417
MDR Text Key109362452
Report Number1627487-2018-05244
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 company representative,consum
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/02/2019
Device Model Number3662
Device Lot Number6079331
Other Device ID Number05415067020222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487-060217-001-C

Patient Treatment Data
Date Received: 05/29/2018 Patient Sequence Number: 1
Treatment
MODEL 2311 (X2), SCS ADAPTER
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