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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL PENTA 3MM LEAD, 60 CM SCS LEAD

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ABBOTT MEDICAL PENTA 3MM LEAD, 60 CM SCS LEAD Back to Search Results
Model Number 3228
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 08/13/2021
Event Type  Injury  
Event Description
Related manufacturer report number: 3006705815-2021-04237. It was reported that the patient had not used their scs system for a while. As result, the system was explanted.
 
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Brand NamePENTA 3MM LEAD, 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 Key12391707
MDR Text Key268922571
Report Number1627487-2021-16622
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,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/28/2014
Device Model Number3228
Device Catalogue Number3228
Device Lot Number3867355
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 Received09/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2012
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: 08/31/2021 Patient Sequence Number: 1
Treatment
SCS IPG, MODEL: 3660
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