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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-1200-S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Swelling (2091); No Code Available (3191)
Event Date 05/06/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: model: db-2202-45, serial/lot: (b)(4), description: dbs directional lead sterile kit 45cm.The explanted devices were not returned to bsn as they were discarded by the medical facility.It is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
A report was received that the patients ipg and leads were explanted due to an infection at the ipg site.The symptoms of the infection included swelling and warmth at the ipg site.The physician does not believe the infection was device related, but it is unknown what caused the infection.
 
Manufacturer Narrative
Additional information was received that the leads were not explanted during the (b)(6) 2019 procedure.However, the infection was not resolved via medication or explant of the ipg.The infection spread to the lead site so the leads were explanted on (b)(6) 2019.
 
Event Description
A report was received that the patients ipg and leads were explanted due to an infection at the ipg site.The symptoms of the infection included swelling and warmth at the ipg site.The physician does not believe the infection was device related, but it is unknown what caused the infection.
 
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Brand Name
VERCISE GEVIA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key8668732
MDR Text Key147015550
Report Number3006630150-2019-02617
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729984443
UDI-Public08714729984443
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 07/15/2019
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 Date01/09/2021
Device Model NumberDB-1200-S
Device Catalogue NumberDB-1200-S
Device Lot Number736248
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/17/2019
Initial Date FDA Received06/04/2019
Supplement Dates Manufacturer Received07/01/2019
Supplement Dates FDA Received07/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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