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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG

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PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG Back to Search Results
Model Number 3662
Device Problem Wireless Communication Problem (3283)
Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 09/01/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated. 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 underwent an unrelated shoulder surgery at an unknown date. Surgery mode was not turned on prior to the procedure. Following the procedure, the ipg would not communicate with external devices. Surgical intervention is expected to resolve the issue.
 
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Brand NamePROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR
Type of DeviceSCS IPG
MDR Report Key12647999
MDR Text Key276894172
Report Number1627487-2021-17777
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/08/2019
Device Model Number3662
Device Catalogue Number3662
Device Lot Number5887525
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2017
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

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