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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG SLIM TIP LEAD
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ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG SLIM TIP LEAD Back to Search Results
Model Number MN10450-50A
Device Problem Therapy Delivered to Incorrect Body Area (1508)
Patient Problem Undesired Nerve Stimulation (1980)
Event Date 06/17/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.Further information was requested but not received.
 
Event Description
Related manufacturer reference number: 1627487-2021-15386.It was reported the patient experienced motor stimulation.In turn, the right l1 lead was explanted to address the issue.Note: all of the patient's leads are being reported because it is unknown which lead is liable.
 
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, 50CM
Type of Device
DRG SLIM TIP LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12127092
MDR Text Key260218723
Report Number1627487-2021-15387
Device Sequence Number1
Product Code PMP
UDI-Device Identifier05415067027153
UDI-Public05415067027153
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,health
Type of Report Initial,Followup
Report Date 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/11/2022
Device Model NumberMN10450-50A
Device Catalogue NumberMN10450-50A
Device Lot Number7528490
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MN10450-50A; MN10450-50A
Patient Outcome(s) Other;
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