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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL DBS LEAD

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ABBOTT MEDICAL DBS LEAD Back to Search Results
Model Number 6172
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Fluid Discharge (2686)
Event Date 11/20/2021
Event Type  Injury  
Manufacturer Narrative
¿date of event¿ is estimated.During processing of this complaint, attempts were made to obtain complete event information and device information.The unique device identifier (udi #) is unknown.
 
Event Description
Related manufacturer reference number: 1627487-2021-18937.It was reported that the lead site wound had fluid discharge.The patient was prescribed iv antibiotics, surgery may have occurred on (b)(6) 2021 to wash out the wound, and patient was hospitalized to address the issue.
 
Event Description
Additional information was received that the issue resolved without sequelae.
 
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.Additional information: section d: certain fields have been updated or entered based on new information.G3 - pma/510(k) #: field has been updated based on new information.H4: date has been entered based on new information.
 
Event Description
Additional related manufacturer reference numbers: 1627487-2022-00824, 1627487-2022-00825.Additional information was received about the original issue that the patient had an allergic reaction on the skin of the forehead and around the cranial wound.
 
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Brand Name
DBS LEAD
Type of Device
DBS 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 Key13041249
MDR Text Key282484862
Report Number1627487-2021-18936
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P140009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/13/2022
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 Date06/27/2022
Device Model Number6172
Device Lot Number7564701
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/08/2021
Initial Date FDA Received12/20/2021
Supplement Dates Manufacturer Received01/13/2022
02/07/2022
Supplement Dates FDA Received02/01/2022
02/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Hospitalization;
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