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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL KIT LEAD EXTENSION, 50CM; DRG EXTENSION
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ABBOTT MEDICAL KIT LEAD EXTENSION, 50CM; DRG EXTENSION Back to Search Results
Model Number MN20550-50
Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Implant Pain (4561)
Event Date 12/07/2020
Event Type  Injury  
Manufacturer Narrative
The results, method, and conclusion codes along with the investigation results will be provided in final report.
 
Event Description
Related manufacturer reference number: 1627487-2021-00136.It was reported the patient experienced pain at the extension site where there is a slight bump.Surgical intervention was undertaken wherein the extensions were explanted and rerouted.
 
Event Description
Additional information was received indicating the pain was caused by fractures in the extensions.
 
Manufacturer Narrative
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 event could not be conclusively determined.
 
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Brand Name
KIT LEAD EXTENSION, 50CM
Type of Device
DRG EXTENSION
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11124999
MDR Text Key225330059
Report Number1627487-2021-00135
Device Sequence Number1
Product Code PMP
Combination Product (y/n)N
PMA/PMN Number
P150004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/02/2021
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? Yes
Device Operator Health Professional
Device Expiration Date02/19/2022
Device Model NumberMN20550-50
Device Catalogue NumberMN20550-50
Device Lot Number7400881
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/21/2020
Initial Date FDA Received01/06/2021
Supplement Dates Manufacturer Received01/14/2021
02/24/2021
Supplement Dates FDA Received01/29/2021
03/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODEL: MN20550-50, DBS EXTENSION.; MODEL: MN20550-50, DBS EXTENSION
Patient Outcome(s) Other;
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