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-2218-70
Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Cut In Material (2454)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Inadequate Pain Relief (2388)
Event Date 12/10/2014
Event Type  Injury  
Event Description
A report was received that the patient¿s pain was worsening and that the leads were hurting the neck.The device was interrogated and some high impedances were noted.It was also reported that the ipg was faulty.The patient will undergo an explant procedure.
 
Event Description
A report was received that the patient¿s pain was worsening and that the leads were hurting the neck.The device was interrogated and some high impedances were noted.It was also reported that the ipg was faulty.The patient will undergo an explant procedure.
 
Manufacturer Narrative
Additional information was received that the patient experienced that the device was shocking her that she requested the explant.The physician meant that the patient was not getting adequate pain relief in the head and neck from the stimulator when he was describing a faulty generator.The patient underwent an explant procedure.The physician did not suspect device malfunction.
 
Manufacturer Narrative
Sc-2218-70 (sn (b)(4)) the complaint was confirmed.The lead was cut during the explant procedure, and the proximal end was not returned.However, two cables were fractured at the bent/kinked section of the lead body, 1 cm from the click anchor set screw mark.There are no exposed cables.Sc-2218-70 (sn (b)(4)) device evaluation indicated that the lead passed mechanical test performed.The lead was cut during the explant procedure, and the proximal end was not returned.However, one of the cables was sharply nicked and cut about 18 centimeters from the distal tip.There were traces of blood around the nicked cable.Sc-4316 (ln 17121174) one of the clik anchors was only nicked.There was no missing silicon material.
 
Event Description
A report was received that the patient¿s pain was worsening and that the leads were hurting the neck.The device was interrogated and some high impedances were noted.It was also reported that the ipg was faulty.The patient will undergo an explant procedure.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: model#: sc-2218-70, serial #: (b)(4), description: linear st lead, 70cm; model#: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator; model#: sc-4316, serial #: (b)(4), description: next generation anchor kit-sterile.
 
Event Description
A report was received that the patient¿s pain was worsening and that the leads were hurting the neck.The device was interrogated and some high impedances were noted.It was also reported that the ipg was faulty.The patient will undergo an explant procedure.
 
Manufacturer Narrative
Additional information was received that the increasing pain was not suspected to be device related.The high impedances were causing the patient to have fluctuations in her stimulation patterns.
 
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 Key4434760
MDR Text Key5527418
Report Number3006630150-2015-00090
Device Sequence Number1
Product Code LGW
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 12/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/13/2015
Device Model NumberSC-2218-70
Other Device ID NumberM365SC2218700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2013
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;
Patient Age44 YR
-
-