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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL; DBS IPG

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ABBOTT MEDICAL; DBS IPG Back to Search Results
Model Number 6660
Device Problem Battery Problem (2885)
Patient Problems Failure of Implant (1924); Movement Disorder (4412)
Event Date 10/02/2023
Event Type  Injury  
Event Description
It was reported that the patient had a worsening of symptoms.Upon checking the dbs system it was observed that the ipg was inoperable.Surgical intervention was undertaken wherein the ipg was explanted and replaced.Effective therapy was restored postoperatively.
 
Manufacturer Narrative
Date of event is estimated.Attempts were made to obtain complete product and patient information.Further information was requested but not received.
 
Manufacturer Narrative
The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
 
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Type of Device
DBS IPG
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 Key18056619
MDR Text Key327179533
Report Number1627487-2023-05205
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P140009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/22/2024
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 Model Number6660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/06/2023
Initial Date FDA Received11/02/2023
Supplement Dates Manufacturer Received02/13/2024
Supplement Dates FDA Received02/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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