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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1160
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
Exact date unknown, event occurred a few days prior to the explant date.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218700, model: sc-2218-70, serial: (b)(4), batch: 7072987/7072999.
 
Event Description
It was reported that the patient had an infection at the ipg site.Symptoms of redness around the ipg site and fever were noted.It was unknown if the infection was device related and what caused it however, the physician believed it was not procedure related.All device components were explanted.
 
Manufacturer Narrative
Sc-1160, (sn: (b)(6)).The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.Sc-2218-70, (sn: (b)(6)).The returned lead were analyzed and the leads were cleanly cut.No anomalies were identified on the leads aside from the clean-cut.The damage to the leads was a result of a typical explant procedure, and it was not considered a failure.
 
Event Description
It was reported that the patient had an infection at the ipg site.Symptoms of redness around the ipg site and fever were noted.It was unknown if the infection was device related and what caused it however, the physician believed it was not procedure related.All device components were explanted and were returned.
 
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Brand Name
SPECTRA WAVEWRITER
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key11646086
MDR Text Key245078907
Report Number3006630150-2021-01494
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729951254
UDI-Public08714729951254
Combination Product (y/n)N
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/18/2021
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 Date07/29/2022
Device Model NumberSC-1160
Device Catalogue NumberSC-1160
Device Lot Number371338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2021
Initial Date Manufacturer Received 03/20/2021
Initial Date FDA Received04/09/2021
Supplement Dates Manufacturer Received04/29/2021
Supplement Dates FDA Received05/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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