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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 Fracture (1260)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/26/2021
Event Type  Injury  
Event Description
It was reported that the patient's lead was displaying invalid impedances on all 16 contacts.It was noted that one tail of the paddle lead was visibly frayed and fractured.As a result, surgical intervention may occur to address the issue.
 
Event Description
It was reported that the lead was explanted and replaced on sep 22, 2021.The patient has effective therapy post operatively.
 
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
Type of Device
SCS PADDLE LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12304407
MDR Text Key265972490
Report Number1627487-2021-16220
Device Sequence Number1
Product Code LGW
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 10/07/2021
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? No
Device Operator Health Professional
Device Expiration Date03/28/2013
Device Model Number3228
Device Lot Number3350867
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/27/2021
Initial Date FDA Received08/10/2021
Supplement Dates Manufacturer Received09/22/2021
Supplement Dates FDA Received10/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight50
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