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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 Problems Premature Discharge of Battery (1057); Unexpected Therapeutic Results (1631); Battery Problem (2885); Wireless Communication Problem (3283)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/10/2021
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: m365sc8352500, model: sc-8352-50, serial: (b)(4), batch: 2000014780.
 
Event Description
It was reported that the patient was not getting an adequate stimulation coverage. It was also noted that the ipg was nonfunctional and was having communication issues. The patient underwent spinal cord stimulator (scs) system replacement procedure and was doing well post operatively.
 
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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 Key12520051
MDR Text Key272937004
Report Number3006630150-2021-05334
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC-1432
Device Catalogue NumberSC-1432
Device Lot Number201665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2020
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: 09/23/2021 Patient Sequence Number: 1
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