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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1132
Device Problems Premature Discharge of Battery (1057); Telemetry Discrepancy (1629); Charging Problem (2892)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/03/2017
Event Type  malfunction  
Event Description
A report was received that the patient had difficulty charging the ipg and communicating the ipg to the remote control (rc).Database analysis (db) revealed that the ipg was showing signs of premature battery depletion.The patient will undergo an ipg replacement procedure.
 
Manufacturer Narrative
Additional information was received that the patient underwent an ipg replacement procedure.The patient was doing well postoperatively.
 
Event Description
A report was received that the patient had difficulty charging the ipg and communicating the ipg to the remote control (rc).Database analysis (db) revealed that the ipg was showing signs of premature battery depletion.The patient will undergo an ipg replacement procedure.
 
Manufacturer Narrative
Correction to the initial mdr: additional information was received that the physician confirmed there was suspected ipg malfunction, but cause was unknown.Sc-1132 (sn: (b)(4)) device evaluation indicated that the complaint of the charging anomaly was confirmed.Upon receipt the device wouldn¿t communicate, and was subsequently charged to 3.94 vdc in two charge cycles.However, the device lost communication during the memory download procedure.The device was cut open and the internal inspection revealed excessive sleep current leakage.A hot spot was observed on the component (28.9°c).The impedance between vh and ground was low.These are the typical symptoms of the asic damage due to exposure to high-voltage transients, causing internal shorts in the component.The patient data indicated fast battery depletion some time prior to the explant procedure.It was reported that patient was unable to recharge his stimulator post-revision surgery.
 
Event Description
A report was received that following a lead explant procedure (mfr report #: 3006630150-2017-01447), the patient had difficulty charging the ipg and communicating the ipg to the remote control (rc).Database analysis (db) revealed that the ipg was showing signs of premature battery depletion.The patient will undergo an ipg replacement procedure.
 
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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 Key6798553
MDR Text Key82835090
Report Number3006630150-2017-03011
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821526
UDI-Public08714729821526
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,Followup
Report Date 07/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/30/2018
Device Model NumberSC-1132
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2016
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 Age72 YR
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