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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

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ABBOTT MEDICAL PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG Back to Search Results
Model Number 3789
Device Problem Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that the patient's ipg was explanted on an unknown date for an unknown reason.Further information is currently unavailable.
 
Manufacturer Narrative
During processing of this incident, attempts were made to obtain complete event and patient information.Further information was requested but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
Related manufacturer report number 1627487-2021-00784.Additional information revealed that the patient's entire system was explanted on an unknown date for an unknown reason.Further information is unavailable.
 
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Brand Name
PROTEGE IPG, 16-CHANNEL RECHARGEABLE
Type of Device
SCS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11111804
MDR Text Key225037099
Report Number1627487-2021-00050
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734405690
UDI-Public05414734405690
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
Type of Report Initial,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2017
Device Model Number3789
Device Catalogue Number3789
Device Lot Number5319027
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/21/2020
Initial Date FDA Received01/04/2021
Supplement Dates Manufacturer Received01/27/2021
Supplement Dates FDA Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
3228, SCS LEAD
Patient Outcome(s) Other;
Patient Age50 YR
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