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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 High impedance (1291)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.The results/ method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported during diagnostics that the patient's l4 drg lead had multiple contacts with high impedance.In turn, surgical intervention may take place at a later date 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.
 
Event Description
Related manufacturer reference number: 1627487-2021-16645, 1627487-2021-16646.Additional information received indicated that during a pre-op appointment the patient's l5 and s1 drg leads also had contacts with high impedance.In turn, surgical intervention was undertaken wherein all the existing leads were 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 Key11097017
MDR Text Key224597016
Report Number1627487-2020-49299
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,consum
Type of Report Initial,Followup,Followup
Report Date 08/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/11/2019
Device Model NumberMN10450-50A
Device Catalogue NumberMN10450-50A
Device Lot NumberAB2354
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DRG LEAD (X2)
Patient Outcome(s) Other;
Patient Age30 YR
Patient Weight59
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