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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 Bacterial Infection (1735); Erosion (1750); Pain (1994); Burning Sensation (2146); Fluid Discharge (2686); Swelling/ Edema (4577)
Event Date 07/08/2021
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, (b)(4).
 
Event Description
It was reported that the patient developed an infection at the ipg site.Symptoms of swelling, pain and fluid discharge were noted.The patients incision site had opened up when the charging tape ripped off while charging the ipg.It was also noted that the ipg was not exposed.The patient was placed on antibiotics.
 
Event Description
It was reported that the patient developed an infection at the ipg site.Symptoms of swelling, pain and fluid discharge were noted.The patients incision site had opened up when the charging tape ripped off while charging the ipg.It was also noted that the ipg was not exposed the patient was placed on antibiotics.Additional information was received that the patients infection was not device related and it was gut related.The patient underwent a spinal cord stimulator (scs) system explant procedure and was doing well post-operatively.The explanted ipg and leads were discarded by the medical facility.
 
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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 Key12318436
MDR Text Key266396839
Report Number3006630150-2021-04499
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 09/09/2021
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 Date01/28/2021
Device Model NumberSC-1160
Device Catalogue NumberSC-1160
Device Lot Number349188
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/23/2021
Initial Date FDA Received08/13/2021
Supplement Dates Manufacturer Received08/19/2021
Supplement Dates FDA Received09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient Weight67
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