• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1160
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Inadequate Pain Relief (2388)
Event Date 09/15/2021
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2366500, model: sc-2366-50, serial: (b)(4), batch: (b)(4). Product family: scs-linear leads, upn: m365sc2366500, model: sc-2366-50, serial: (b)(4), batch: (b)(4). Product family: scs-linear leads upn: m365sc2218700 model: sc-2218-70 serial: (b)(4), batch: (b)(4).
 
Event Description
It was reported that the patient was experiencing inadequate pain relief. The patient received therapy in the middle back however due to lead placement, therapy was unable to be spread to the lower back and legs. The patient underwent an explant procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12616520
MDR Text Key275933758
Report Number3006630150-2021-05715
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC-1160
Device Catalogue NumberSC-1160
Device Lot Number369273
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2020
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: 10/12/2021 Patient Sequence Number: 1
-
-