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U.S. Department of Health and Human Services

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

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ABBOTT MEDICAL PENTA 3MM LEAD, 60 CM SCS PADDLE LEAD Back to Search Results
Model Number 3228
Device Problems High impedance (1291); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Headache (1880); Inadequate Pain Relief (2388)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
Event and therapy dates are estimated. The results/method and conclusion codes along with the investigation results will be provided in the final report.
 
Event Description
Related manufacturing reference number: 1627487-2020-49335; related manufacturing reference number: 1627487-2020-49336; related manufacturing reference number: 1627487-2020-49338. It was reported patient experienced ineffective therapy and has headaches. X-rays did not indicate any anomalies. Diagnostics indicated impedance issues. System may be removed at a later date.
 
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Brand NamePENTA 3MM LEAD, 60 CM
Type of DeviceSCS PADDLE 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 Key11092343
MDR Text Key224248741
Report Number1627487-2020-49333
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2014
Device Model Number3228
Device Catalogue Number3228
Device Lot Number3677404
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 Received01/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2012
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: 12/29/2020 Patient Sequence Number: 1
Treatment
MODEL 3386,SCS EXT X 2; MODEL 3660,SCS IPG
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