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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 Difficult to Insert (1316); Unexpected Therapeutic Results (1631)
Patient Problem No Code Available (3191)
Event Date 09/24/2020
Event Type  Injury  
Manufacturer Narrative
Exact date unknown, event occurred in (b)(6) 2020.
 
Event Description
It was reported that the patient was experiencing ineffective therapy. It was also stated that during the procedure the physician was unable to plug in the non boston scientific leads to the boston scientific ipg. The patient underwent a revision procedure wherein the non boston scientific leads was replaced with a boston scientific leads.
 
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Brand NameSPECTRA WAVEWRITER
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 Key10827893
MDR Text Key215888319
Report Number3006630150-2020-05506
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC-1160
Device Catalogue NumberSC-1160
Device Lot Number372153
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2020
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: 11/12/2020 Patient Sequence Number: 1
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