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U.S. Department of Health and Human Services

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

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ABBOTT MEDICAL 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 05/01/2021
Event Type  malfunction  
Event Description
It was reported patient was unable to connect with external devices around (b)(6) of 2021. It was also stated that patient had an unrelated procedure around that time. Company manufacturers tried to trouble shoot and the ipg was found not to be in a bondable state and deemed inoperable. No further plan of action at this time.
 
Manufacturer Narrative
Date of event is estimated.
 
Manufacturer Narrative
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. The device was not returned for analysis; however, data logs was received. Based on the information received, the cause of the reported incident is consistent with user error.
 
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Brand NamePROCLAIM¿ 7 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 Key12930156
MDR Text Key281746321
Report Number1627487-2021-18729
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,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/15/2018
Device Model Number3662
Device Catalogue Number3662
Device Lot Number5597938
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2016
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: 12/03/2021 Patient Sequence Number: 1
Treatment
SCS LEAD
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