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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B; DBS EXTENSION

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ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B; DBS EXTENSION Back to Search Results
Model Number 6371
Device Problem Failure to Advance (2524)
Patient Problem Inadequate Pain Relief (2388)
Event Date 04/04/2022
Event Type  Injury  
Event Description
Related manufacturer reference number: 1627487-2022-02650.It was reported that during a routine ipg replacement the patients extension was unable to be inserted into the new ipg.Reportedly the extension had lost its stiffness.Additional information was received indicating surgical intervention took place on 4 apr 2022 wherein the extensions were explanted and replaced.
 
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 and event information.
 
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Brand Name
8CH INFINITY DBS FLEX EXTN KIT, 50CM, 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
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key14630943
MDR Text Key293526973
Report Number1627487-2022-03203
Device Sequence Number1
Product Code MHY
UDI-Device Identifier05415067020307
UDI-Public05415067020307
Combination Product (y/n)N
Reporter Country CodeAS
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 09/13/2022
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 Date05/08/2019
Device Model Number6371
Device Catalogue Number6371
Device Lot Number5967959
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/25/2022
Initial Date FDA Received06/08/2022
Supplement Dates Manufacturer Received09/07/2022
Supplement Dates FDA Received09/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2017
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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