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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
Medical Device Problem Codes Fracture (1260); High impedance (1291)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/24/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that during an intraoperative testing diagnostic revealed high impedance.As such, the lead was explanted and replaced with a new lead to address the issue.It was noted that the lead had breakage.Reportedly, therapy was confirmed post operatively.
 
Additional 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
PENTA 3MM LEAD, 60 CM
Common Device Name
SCS LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12162031
Report Number1627487-2021-15581
Device Sequence Number20037915
Product Code LGW
UDI-Device Identifier05414734405300
UDI-Public05414734405300
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/22/2021
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
Operator of Device Health Professional
Device Expiration Date01/28/2016
Device Model Number3228
Device Catalogue Number3722
Device Lot Number4410160
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/24/2021
Supplement Date Received by Manufacturer07/16/2021
Initial Report FDA Received Date07/13/2021
Supplement Report FDA Received Date07/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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