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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 7 ELITE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 7 ELITE SCS IPG Back to Search Results
Model Number 3662
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/12/2019
Event Type  Injury  
Manufacturer Narrative
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 was unable to establish a connection between the ipg and the patient controller (pc). A company representative met with the patient and confirmed the issue by also using the clinician programmer (cp). The cp displayed an error message: "ipg repair attempted, the programmer will reconnect when ipg is ready. " the representative attempted multiple times to connect to the ipg, but to no avail. The patient stated they underwent a surgical procedure and did not place the device into surgery mode prior to surgery. In turn, the patient may undergo surgical intervention as the next course of action.
 
Event Description
It was reported that the patient underwent surgical intervention wherein the scs ipg was explanted and replaced to address the issue.
 
Manufacturer Narrative
A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system. The results of the investigation are inconclusive since the device was not returned for analysis. Actions have been taken to prevent reoccurrence.
 
Manufacturer Narrative
The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery was used. A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system. The results of the investigation are inconclusive since the device was not returned for analysis. Actions have been taken to prevent reoccurrence.
 
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Brand NamePROCLAIM 7 ELITE
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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8951895
MDR Text Key156263301
Report Number3006705815-2019-03356
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,Followup,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/11/2020
Device Model Number3662
Device Lot NumberA000067943
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/06/02/2017/001-C

Patient Treatment Data
Date Received: 08/30/2019 Patient Sequence Number: 1
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