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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2021
Event Type  Injury  
Manufacturer Narrative
Further information requested, but not yet received.
 
Event Description
Related manufacturer reference number:1627487-2021-15079.It was reported that during an ipg replacement procedure on (b)(6) 2021 [related manufacturer reference number: 1627487-2021-15082], the physician was unable to insert the extensions into the new ipg.As a result, the extensions were explanted and replaced resolving the issue.
 
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 incident could not be conclusively determined.
 
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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
MDR Report Key12071007
MDR Text Key258696846
Report Number1627487-2021-15080
Device Sequence Number1
Product Code MHY
UDI-Device Identifier05415067030344
UDI-Public05415067030344
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 07/26/2021
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? No
Device Operator Health Professional
Device Expiration Date11/05/2022
Device Model Number6371
Device Catalogue Number6371
Device Lot Number7726123
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/10/2021
Initial Date FDA Received06/25/2021
Supplement Dates Manufacturer Received07/23/2021
Supplement Dates FDA Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DBS EXTENSION
Patient Outcome(s) Other;
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