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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
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2020
Event Type  Injury  
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 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
Type of Device
SCS EXTENSION
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 Key11084989
MDR Text Key224058048
Report Number1627487-2020-49268
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067016683
UDI-Public05415067016683
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 consumer
Reporter Occupation Physician
Type of Report Initial
Report Date 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
Device Operator Health Professional
Device Expiration Date03/31/2017
Device Model Number2316
Device Catalogue Number2316
Device Lot Number5057682
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SCS EXTENSION; SCS IPG
Patient Outcome(s) Other;
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