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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 Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/15/2019
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 that the patient cannot connect to their ipg. The patient had a surgery several months ago and did not use surgery mode. The patient may undergo surgical intervention to have their ipg replaced.
 
Event Description
It was reported that the patient has effective therapy.
 
Manufacturer Narrative
An inoperable ipg was reported to abbott. 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 device was not returned for analysis; however, data logs was received. Analysis of the record shows that the system was unable to successfully establish a connection with the clinician programmer. Actions have been taken to prevent reoccurrence.
 
Manufacturer Narrative
An inoperable implant was reported to abbott. The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used. The implant was not returned for analysis. A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system. Based on the information received, the cause of the reported incident is consistent with user error.
 
Event Description
It was reported that the patient had their ipg explanted and replaced.
 
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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
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8864238
MDR Text Key153369161
Report Number1627487-2019-08808
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,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/06/2019
Device Model Number3662
Device Lot Number6147513
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 Received01/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/06/02/2017/001-C

Patient Treatment Data
Date Received: 08/06/2019 Patient Sequence Number: 1
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