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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 90CM; DRG LEAD
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ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 90CM; DRG LEAD Back to Search Results
Model Number MN20450-90A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Numbness (2415)
Event Date 10/07/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 1627487-2020-33101.Related manufacturer reference number: 1627487-2020-33103.It was reported that the patient was experiencing post-op surgical pain and light numbness in the upper thigh.The patient was hospitalized and ct scans showed no adverse findings.As a result, the physician removed the patient's leads.
 
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 SLIM TIP LEAD, 90CM
Type of Device
DRG LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10771119
MDR Text Key214131815
Report Number1627487-2020-33102
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 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/23/2022
Device Model NumberMN20450-90A
Device Lot Number7348120
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MN20450-90A X 2; MN20450-90A X 2
Patient Outcome(s) Hospitalization; Other;
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