Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 PRECISION SPECTRA; SPINAL CORD STIMULATOR
  • 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 PRECISION SPECTRA; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-8216-70
Device Problems Bent (1059); Migration or Expulsion of Device (1395); No Device Output (1435); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2018
Event Type  Injury  
Event Description
A report was received that during a revision procedure the patients lead was observed that five contacts were displaced and the remaining contacts were pulled backwards.It was noted that prior to the surgery, the patient had a major fall and lost stimulation.X-rays revealed that the lead had migrated and partially bent and rotated.The patient underwent a lead replacement procedure and all displaced contacts were removed.Device malfunction was suspected.The patient was doing well postoperatively.
 
Manufacturer Narrative
Sc-8216-70, sn: (b)(4), device evaluation indicated that the lead's visual inspection revealed that the lead was cleanly cut approximately 46 cm from the proximal end.The paddle end of the lead was not returned.The damage to the lead is consistent with damages done during the explant procedure and it is not considered a failure.
 
Event Description
A report was received that during a revision procedure the patients lead was observed that five contacts were displaced and the remaining contacts were pulled backwards.It was noted that prior to the surgery, the patient had a major fall and lost stimulation.X-rays revealed that the lead had migrated and partially bent and rotated.The patient underwent a lead replacement procedure and all displaced contacts were removed.Device malfunction was suspected.The patient was doing well postoperatively.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRECISION SPECTRA
Type of Device
SPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key7575349
MDR Text Key110287727
Report Number3006630150-2018-02016
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729779919
UDI-Public08714729779919
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/31/2018
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 Date01/23/2019
Device Model NumberSC-8216-70
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2018
Initial Date FDA Received06/06/2018
Supplement Dates Manufacturer Received07/18/2018
Supplement Dates FDA Received07/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-