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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE LEAD, 50CM, AU; DRG LEAD
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ABBOTT MEDICAL KIT IMPLANTABLE LEAD, 50CM, AU; DRG LEAD Back to Search Results
Model Number MN20450-50AU
Device Problems Material Fragmentation (1261); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information requested but not received.
 
Event Description
Related manufacturer reference number: 1627487-2020-33384; related manufacturer reference number: 1627487-2020-33385; related manufacturer reference number: 1627487-2020-33386.It was reported that the patient's lead revision (related manufacturer reference number: 1627487-2020-47703) was abandoned.Reportedly, the physician had great difficulty removing the patient's leads because they were intertwined with each other, as well as the presence of fibrous tissue around the leads.As a result, one partial lead and one contact was left implanted in the patient.
 
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
KIT IMPLANTABLE LEAD, 50CM, AU
Type of Device
DRG LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10825421
MDR Text Key215878010
Report Number1627487-2020-33387
Device Sequence Number1
Product Code PMP
Combination Product (y/n)N
PMA/PMN Number
P150004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2015
Device Model NumberMN20450-50AU
Device Lot NumberAB1308
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MN20450-50AU X 3
Patient Outcome(s) Other;
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