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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 Failure to Charge (1085)
Patient Problem No Code Available (3191)
Event Date 02/21/2019
Event Type  Injury  
Event Description
A report was received that the patients ipg was not holding a charge.The patient underwent an ipg replacement procedure and was doing well postoperatively.No device malfunction was suspected.
 
Event Description
A report was received that the patients ipg was not holding a charge.The patient underwent an ipg replacement procedure and was doing well postoperatively.No device malfunction was suspected.
 
Manufacturer Narrative
Model: sc-1160 (sn: (b)(4)).Device evaluation indicated that the ipg passed all tests performed and revealed no anomalies.
 
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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 Key8582396
MDR Text Key144141011
Report Number3006630150-2019-02064
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 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/09/2020
Device Model NumberSC-1160
Device Catalogue NumberSC-1160
Device Lot Number338697
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2019
Date Manufacturer Received05/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age86 YR
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