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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number NM-3138-55
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Blood Loss (2597); No Code Available (3191)
Event Date 12/15/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Additional suspect medical device components involved: product family: dbs-extension, upn: (b)(4), model: nm-3138-55, serial: (b)(4), batch: 7075345.Product family: dbs-ipg-r-mri, upn: (b)(4), model: db-1200-s, serial: (b)(4), batch: 740793.
 
Event Description
It was reported that during a deep brain stimulator dbs implant procedure, following tunneling, the patient was bleeding excessively from a site near the ipg pocket incision.Pressure was applied on and off for over an hour but the bleeding continued.A thoracic surgeon was brought in and assessed that the extension may have penetrated the jugular vein which would of caused the excessive bleeding.The extensions were removed and tunneled again at the site more distal from the neck.The bleeding reduced.Following suturing and the application of bandages, an increase of swelling was noticed around the ipg pocket site and up near the clavicle.Pressure bandages were applied to keep weight on the site of the bleeding.The patient was admitted overnight to monitor the swelling.The swelling has since dissipated and the patients was noted to be fully recovered.
 
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Brand Name
NA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
RQ   00646-2602
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key11050913
MDR Text Key223057858
Report Number3006630150-2020-06307
Device Sequence Number1
Product Code MHY
UDI-Device Identifier08714729820765
UDI-Public08714729820765
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/21/2020
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? Yes
Device Operator Health Professional
Device Expiration Date03/04/2022
Device Model NumberNM-3138-55
Device Catalogue NumberNM-3138-55
Device Lot Number7075373
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2020
Initial Date FDA Received12/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2020
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) Hospitalization; Required Intervention;
Patient Age69 YR
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