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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL CINCH LEAD ANCHOR; SCS ANCHOR
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ABBOTT MEDICAL CINCH LEAD ANCHOR; SCS ANCHOR Back to Search Results
Model Number 1194
Device Problem Fracture (1260)
Patient Problem Inadequate Pain Relief (2388)
Event Date 01/21/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.
 
Event Description
Related manufacturer report: 1627487-2021-00602.It was reported that upon x-ray observation lead and lead anchor damage was confirmed.Diagnostic testing confirmed high impedance issue as well.The lead and anchor was explanted and a new lead and anchor was implanted.There were no complications during the procedure.Patient was stable.
 
Manufacturer Narrative
The reported event of break/fracture was visually confirmed.As received, the anchor was broke into two segments beyond functional testing.The breakage is consistent with overstress condition that the lead was subjected while in vivo.
 
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Brand Name
CINCH LEAD ANCHOR
Type of Device
SCS ANCHOR
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11234071
MDR Text Key228833707
Report Number1627487-2021-00603
Device Sequence Number1
Product Code GZB
UDI-Device Identifier05415067024091
UDI-Public05415067024091
Combination Product (y/n)N
PMA/PMN Number
K081208
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/27/2021
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? Yes
Device Operator Health Professional
Device Expiration Date05/22/2021
Device Model Number1194
Device Catalogue Number1194
Device Lot Number6999583
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/21/2021
Initial Date FDA Received01/26/2021
Supplement Dates Manufacturer Received02/22/2021
Supplement Dates FDA Received02/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS LEAD.; SCS LEAD
Patient Outcome(s) Other;
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