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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 SLIM TIP LEAD
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ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 90CM; DRG SLIM TIP LEAD Back to Search Results
Model Number MN10450-90A
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 12/08/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.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 or Problem Description
Manufacturer reference number: 1627487-2020-49105.It was reported that the patient experienced lead migration, and it was confirmed with x-ray.During procedure on (b)(6) 2020 the other lead migrated.Physician explanted and replaced both leads, and therapy was restored.
 
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Brand Name
KIT IMPLANTABLE SLIM TIP LEAD, 90CM
Common Device Name
DRG SLIM TIP LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11068658
Report Number1627487-2020-49106
Device Sequence Number17203725
Product Code PMP
UDI-Device Identifier05415067025586
UDI-Public05415067025586
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
P150004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/23/2020
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
Operator of Device Health Professional
Device Expiration Date04/19/2019
Device Model NumberMN10450-90A
Device Catalogue NumberMN10450-90A
Device Lot NumberAB2292
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/08/2020
Initial Report FDA Received Date12/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Weight85
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