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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG Back to Search Results
Model Number 3660
Device Problem Wireless Communication Problem (3283)
Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 06/01/2021
Event Type  Injury  
Manufacturer Narrative
Event date is an estimate. 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. 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 patient underwent an unrelated surgical procedure and failed to place the ipg into surgery mode. Later on patient was unable to communicate with external devices and ipg was deemed inoperable. As such, surgical intervention took place wherein the ipg was replaced and reportedly effective therapy was restored.
 
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Brand NamePROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
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
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key12510226
MDR Text Key272657417
Report Number3006705815-2021-04705
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
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/23/2021
Device Model Number3660
Device Catalogue Number3660
Device Lot NumberA000087070
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 Received09/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2019
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: 09/21/2021 Patient Sequence Number: 1
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