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-1132
Device Problems Telemetry Discrepancy (1629); Device Inoperable (1663); Charging Problem (2892)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2017
Event Type  malfunction  
Event Description
A report was received that the patient was having telemetry issues and had difficulty charging ipg out of hibernation following a recent revision.It was also noted that the ipg was non-functional after implant.Database analysis (db) showed normal values.The patient underwent an ipg replacement procedure and was doing well postoperatively.Electrocautery is a known source of high voltage transient signal and current company labeling warns against the use of electrocautery.(physician¿s implant manual (b)(4)).
 
Manufacturer Narrative
Sc-1132 (sn: (b)(4)) device evaluation indicated that the complaint was confirmed.The device could not be charged nor linked.The device was no longer functioning due to asic-u2 damage.The sleep current measured high and the vh impedance measured low resistance.It was reported that the symptom appeared after the previous procedure where a medtronic plasma blade was used.The use of the plasma blade resulted in the asic-u2 damage.
 
Event Description
A report was received that the patient was having telemetry issues and had difficulty charging ipg out of hibernation following a recent revision.It was also noted that the ipg was non-functional after implant.Database analysis (db) showed normal values.The patient underwent an ipg replacement procedure and was doing well postoperatively.Electrocautery is a known source of high voltage transient signal and current company labeling warns against the use of electrocautery.(physician¿s implant manual (b)(4)).
 
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 Key6724904
MDR Text Key80434329
Report Number3006630150-2017-02617
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821526
UDI-Public(01)08714729821526(17)180725(10)19505351
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 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/25/2018
Device Model NumberSC-1132
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2016
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 Age39 YR
-
-