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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 30CM, 1.5, B
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ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 30CM, 1.5, B Back to Search Results
Model Number 6171
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Intracranial Hemorrhage (1891)
Date of Event 09/27/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with the investigation results will be provided in the final report.
 
Event or Problem Description
It was reported a perifocal hemorrhage at the patient's right dbs lead site occurred.The patient was administered medication and the issue resolved over time.Ct scan results further confirmed resolution.
 
Additional 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. .
 
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Brand Name
8CH INFINITY DBS LEAD KIT, 30CM, 1.5, B
Common Device Name
DBS LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10779390
Report Number1627487-2020-33232
Device Sequence Number1024645
Product Code MHY
UDI-Device Identifier05415067030313
UDI-Public05415067030313
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P140009
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 01/08/2021
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
Operator of Device Health Professional
Device Expiration Date03/18/2022
Device Model Number6171
Device Catalogue Number6171
Device Lot Number7439643
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/12/2020
Supplement Date Received by Manufacturer12/17/2020
Initial Report FDA Received Date11/03/2020
Supplement Report FDA Received Date01/09/2021
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;
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