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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B

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ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B Back to Search Results
Model Number 6173
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paresis (1998); Movement Disorder (4412)
Event Date 06/01/2021
Event Type  Injury  
Event Description
Related manufacturer reference number: 1627487-2021-14962.It was reported the patient experienced right side facial droop and dysarthria immediately following dbs lead implant procedure.Scans did not show signs of stroke.Both the dysarthria and facial droop have improved without intervention.
 
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.During processing of this complaint, attempts were made to obtain complete device, patient and event information.
 
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Brand Name
8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B
Type of Device
DBS LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12028263
MDR Text Key257154193
Report Number1627487-2021-14961
Device Sequence Number1
Product Code MHY
UDI-Device Identifier05415067020697
UDI-Public05415067020697
Combination Product (y/n)N
PMA/PMN Number
P140009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/06/2021
Device Model Number6173
Device Catalogue Number6173
Device Lot Number7108770
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODEL: 6173, DBS LEAD
Patient Outcome(s) Other;
Patient Age76 YR
Patient Weight87
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