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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG

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ABBOTT MEDICAL PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG Back to Search Results
Model Number 3660
Device Problem Wireless Communication Problem (3283)
Patient Problem Inadequate Pain Relief (2388)
Event Date 10/11/2021
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
Related manufacturer reference number: 3006705815-2021-05176. It was reported that following and unrelated surgical procedure where the ipg was not placed into surgery mode, the ipg became unable to communicate with external devices. As a result, surgical intervention was undertaken on (b)(6) 2021 wherein the ipg was explanted and replaced, it was noted during the procedure that the lead became dislocated and it was also replaced.
 
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Brand NamePROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
Type of DeviceSCS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key12724297
MDR Text Key279257349
Report Number1627487-2021-17815
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/10/2021
Device Model Number3660
Device Catalogue Number3660
Device Lot Number6980146
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2019
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: 10/29/2021 Patient Sequence Number: 1
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