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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 11/04/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.
 
Event Description
Related manufacturer reference numbers: 1627487-2020-48188, 1627487-2021-01981.It was reported the patient experienced uncomfortable stimulation from the ipg site.In turn, the system was explanted and replaced to address the issue.
 
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 Key11455474
MDR Text Key238928140
Report Number1627487-2021-01980
Device Sequence Number1
Product Code PMP
UDI-Device Identifier05415067025531
UDI-Public05415067025531
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 07/01/2021
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 Date06/13/2019
Device Model NumberMN10450-50A
Device Catalogue NumberMN10450-50A
Device Lot NumberAB2342
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/19/2021
Initial Date FDA Received03/10/2021
Supplement Dates Manufacturer Received06/30/2021
Supplement Dates FDA Received07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DRG IPG.; DRG SLIM TIP LEAD.; DRG IPG; DRG SLIM TIP LEAD
Patient Outcome(s) Other;
Patient Weight104
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