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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 Problem Disconnection (1171)
Patient Problem Inadequate Pain Relief (2388)
Event Date 10/13/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.The results/ method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 3006705815-2020-32348.It was reported that the patient experienced ineffective therapy.Troubleshooting revealed the lead to be partially pulled out of the header.As a result, surgical intervention was undertaken on (b)(6) 2020 wherein the lead was explanted and replaced.Issue resolved.
 
Manufacturer Narrative
The reported issue of high impedance was confirmed.As received, the penta had multiple broken wires in both lead bodies.The root cause is consistent with the lead being subjected to overstress while in vivo.
 
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Brand Name
PENTA 3MM LEAD, 60 CM
Type of Device
SCS PADDLE LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10767343
MDR Text Key214092854
Report Number1627487-2020-33065
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067017253
UDI-Public05415067017253
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/10/2020
Device Model Number3228
Device Catalogue Number3228
Device Lot Number6617126
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS IPG
Patient Outcome(s) Other;
Patient Weight73
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