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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCH LEAD ANCHOR; SCS ANCHOR
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CINCH LEAD ANCHOR; SCS ANCHOR Back to Search Results
Model Number 1194
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 08/19/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.Reporter phone number: (b)(6).
 
Event Description
Related manufacturer reference number: 3006705815-2021-05019, 3006705815-2021-05022, 3006705815-2021-05024, 1627487-2021-17613, 1627487-2021-17614, 1627487-2021-17615.It was reported the patient experienced an infection.Surgical intervention took place wherein the system was explanted.Infection was treated with regular ab prophylaxis during surgery, plus extra rinsing with cefazolin during ipg implant plus 5 days of 600mg clindamycin 3dd.This was prolonged, later switched to floxapen.
 
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.
 
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Brand Name
CINCH LEAD ANCHOR
Type of Device
SCS ANCHOR
MDR Report Key12657379
MDR Text Key277161656
Report Number1627487-2021-17617
Device Sequence Number1
Product Code GZB
UDI-Device Identifier05414734400688
UDI-Public05414734400688
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 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1194
Device Catalogue Number1194
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/28/2021
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
Treatment
MODEL 1194 ANCHOR; MODEL 3186 X 2 LEADS; MODEL 3386 X 2 EXTENSIONS; MODEL 3660 IPG; MODEL 1194 ANCHOR; MODEL 3186 X 2 LEADS; MODEL 3386 X 2 EXTENSIONS; MODEL 3660 IPG
Patient Outcome(s) Other;
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