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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 Problems Charging Problem (2892); Migration (4003)
Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Fluid Discharge (2686)
Event Date 05/03/2021
Event Type  Injury  
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.
 
Event Description
It was reported that the patient had an infection at the ipg site.A small open weeping area was noted near the incision.The physician believed that the infection was from multiple charging agitation, as the ipg was slanted and connection with the charging disc was difficult.The patient had been icing the wound on and off as ordered by the physician and was instructed to refrain from charging or using the device until wound has fully healed.The patient was also prescribed antibiotics.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-paddle leads; upn: m365sc8336700; model: sc-8336-70; batch: 7071001.
 
Event Description
It was reported that the patient had an infection at the ipg site.A small open weeping area was noted near the incision.The physician believed that the infection was from multiple charging agitation, as the ipg was slanted and connection with the charging disc was difficult.The patient has been icing the wound on and off as ordered by the physician and was instructed to refrain from charging or using the device until wound has fully healed.The patient was also prescribed antibiotics.Additional information was received that patient was in the er (emergency room) due to incision at the pocket site was opened, therefore the physician decided to explant all the devices.The explanted devices were discarded.
 
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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 Key11879212
MDR Text Key252734187
Report Number3006630150-2021-02370
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 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/09/2023
Device Model NumberSC-1160
Device Catalogue NumberSC-1160
Device Lot Number378326
Was Device Available for Evaluation? No
Date Manufacturer Received06/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
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