Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE PRIMARY CELL IPG; DEEP BRAIN STIMULATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC NEUROMODULATION VERCISE PRIMARY CELL IPG; DEEP BRAIN STIMULATOR Back to Search Results
Model Number DB-1140
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Post Operative Wound Infection (2446)
Event Date 10/07/2016
Event Type  Injury  
Manufacturer Narrative
Date of birth: (b)(6) (the exact date is unknown).
 
Event Description
A report was received that the patient had a two day history of redness and pain at the ipg site.The patient was admitted to the hospital due to a superficial wound infection and erythema around the ipg site on the chest.The patient was treated with oral antibiotics and recovered.The patient was discharged from the hospital.The reported event was related to the ipg and causally related to the procedure.
 
Manufacturer Narrative
Additional information has been received from the physician that the reported issue is not related to stimulation.
 
Event Description
A report was received that the patient had a two day history of redness and pain at the ipg site.The patient was admitted to the hospital due to a superficial wound infection and erythema around the ipg site on the chest.The patient was treated with oral antibiotics and recovered.The patient was discharged from the hospital.The reported event was related to the ipg and causally related to the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VERCISE PRIMARY CELL IPG
Type of Device
DEEP BRAIN STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key7285958
MDR Text Key100567977
Report Number3006630150-2018-00761
Device Sequence Number1
Product Code NHL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/23/2018
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 Lay User/Patient
Device Expiration Date02/25/2018
Device Model NumberDB-1140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2018
Initial Date FDA Received02/21/2018
Supplement Dates Manufacturer Received05/16/2018
Supplement Dates FDA Received05/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2016
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;
-
-