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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 09/13/2022
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.During processing of this incident, attempts were made to obtain patient's weight, but it was not received.The allegation is against 1 of 4 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: lead, model: lmn10450-50a, udi: (b)(4), serial: (b)(4), batch:7597646.Lead, model: lmn10450-50a, udi: (b)(4), serial: (b)(4), batch:7597646.Lead, model: lmn10450-50a, udi: (b)(4), serial: (b)(4), batch:7597646.
 
Event Description
It was reported the patient was experiencing motor stimulation.Surgical intervention is planned to address the issue.
 
Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
 
Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
 
Event Description
Additional information received indicated that the patient underwent surgical intervention on (b)(6) 2022 where the lead was repositioned.
 
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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
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key15581048
MDR Text Key301505039
Report Number1627487-2022-05542
Device Sequence Number1
Product Code PMP
UDI-Device Identifier05415067027153
UDI-Public05415067027153
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/15/2022
Device Model NumberMN10450-50A
Device Catalogue NumberMN10450-50A
Device Lot Number7582365
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SCS IPG (X1)
Patient Outcome(s) Other;
Patient SexMale
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