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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1432
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seroma (2069); Fluid Discharge (2686)
Event Date 04/03/2021
Event Type  Injury  
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event. Additional suspect medical device component involved in the event: product family: scs-paddle leads, upn: (b)(4), model: sc-8352-50, serial: (b)(4), batch: 2000023583.
 
Event Description
It was reported that the patient went to the emergency room due to having lots of clear fluid coming out of the ipg site. A computerized tomography (ct) scan was taken and revealed copious amounts of fluid in the ipg pocket site. The patient was administered with intravenous (iv) antibiotics and was recommended by the er physician to stay in the hospital overnight however, the patient refused to stay. The patient underwent a spinal cord stimulator (scs) system explant procedure and was still in the hospital receiving iv antibiotics.
 
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Brand NameWAVEWRITER ALPHA PRIME
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key11720298
MDR Text Key247206237
Report Number3006630150-2021-01759
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC-1432
Device Catalogue NumberSC-1432
Device Lot Number201876
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/23/2021 Patient Sequence Number: 1
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