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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL 8-CHANNEL ADAPTER, MDT, 60CM; SCS EXTENSION
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ABBOTT MEDICAL 8-CHANNEL ADAPTER, MDT, 60CM; SCS EXTENSION Back to Search Results
Model Number 2316
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/08/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.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 or Problem Description
Related manufacturer reference number: 3006705815-2020-33446, 1627487-2020-49269.It was reported the patient underwent surgical intervention on an unknown date wherein their entire system was explanted for an unknown reason.
 
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Brand Name
8-CHANNEL ADAPTER, MDT, 60CM
Common Device Name
SCS EXTENSION
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11084989
Report Number1627487-2020-49268
Device Sequence Number16811052
Product Code LGW
UDI-Device Identifier05415067016683
UDI-Public05415067016683
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/28/2020
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
Operator of Device Health Professional
Device Expiration Date03/31/2017
Device Model Number2316
Device Catalogue Number2316
Device Lot Number5057682
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/08/2020
Initial Report FDA Received Date12/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
SCS EXTENSION; SCS IPG
Outcome Attributed to Adverse Event Other;
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