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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 IMPLANTABLE PULSE GENERATOR SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG Back to Search Results
Model Number 3662
Device Problem Wireless Communication Problem (3283)
Patient Problem Inadequate Pain Relief (2388)
Event Date 03/13/2022
Event Type  malfunction  
Manufacturer Narrative
An inoperable implant was reported to abbott. It is unknown if the system was set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used. A rep was able to successfully restore communication with the device. Therapy was restored. 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. During processing of this incident, attempts were made to obtain complete patient information. Event date is an estimate.
 
Event Description
It was reported the patient's ipg was unable to communicate with external devices. A manufacturer representative interrogated the ipg resolving the issue.
 
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Brand NamePROCLAIM¿ 7 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 Key13968069
MDR Text Key288389939
Report Number3006705815-2022-01660
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3662
Device Catalogue Number3662
Device Lot NumberA000111625
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2021
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: 03/31/2022 Patient Sequence Number: 1
Treatment
SCS LEAD
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