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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD WIDE SPACED, 60 CM SCS LEAD

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ABBOTT MEDICAL QUATTRODE LEAD WIDE SPACED, 60 CM SCS LEAD Back to Search Results
Model Number 3166
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 07/29/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated. The device history record was reviewed to ensure proper packaging and sterility. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
Related manufacturer reference number 1627487-2021-16283. Related manufacturer reference number 1627487-2021-16287. It was reported that patient experienced infection at lead site. Patient was treated with antibiotics and underwent surgical intervention wherein the entire was explanted to address the issue.
 
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Brand NameQUATTRODE LEAD WIDE SPACED, 60 CM
Type of DeviceSCS LEAD
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 Key12315936
MDR Text Key266301438
Report Number1627487-2021-16281
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/14/2021
Device Model Number3166
Device Catalogue Number3166
Device Lot Number6798734
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/12/2021 Patient Sequence Number: 1
Treatment
SCS LEADS X2
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