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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B; DBS EXTENSION

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ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B; DBS EXTENSION Back to Search Results
Model Number 6372
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Movement Disorder (4412)
Event Date 03/12/2024
Event Type  Injury  
Manufacturer Narrative
Section b3: 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
It was reported that right extension was severed, most likely due to a clavicle injury after patient fell off a ladder.There were impedances on five out of the eight contacts.Surgical intervention was undertaken wherein the right extension was explanted and replaced.Effective therapy was restored.
 
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Brand Name
8CH INFINITY DBS FLEX EXTN KIT, 60CM, B
Type of Device
DBS 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
heidi syndergaard
6901 preston road
plano, TX 75024
9723098000
MDR Report Key19001392
MDR Text Key338879729
Report Number1627487-2024-07804
Device Sequence Number1
Product Code MHY
UDI-Device Identifier05415067030351
UDI-Public05415067030351
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/28/2024
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 Date10/14/2022
Device Model Number6372
Device Lot Number7690731
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/12/2024
Initial Date FDA Received03/28/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/14/2020
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
DBS BURR HOLE CAP (1); DBS IPG (1); DBS LEAD (1)
Patient Outcome(s) Other;
Patient SexMale
Patient Weight59 KG
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