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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Shaking/Tremors (2515); Patient Problem/Medical Problem (2688)
Event Date 12/05/2016
Event Type  Injury  
Event Description
A report was received that the patient was hospitalized due to spiking blood pressure and tremors in the hands.It was also reported that the patient was getting stimulation in the head and neck even when the stimulator was off.The physician's in the hospital did not confirm whether it was caused by the stimulator or not, thus the patient was provided with medication.
 
Manufacturer Narrative
Additional information was received that the physician believed that patient's tingling sensation was not device related.No further course of action at this time.
 
Event Description
A report was received that the patient was hospitalized due to spiking blood pressure and tremors in the hands.It was also reported that the patient was getting stimulation in the head and neck even when the stimulator was off.The physician's in the hospital did not confirm whether it was caused by the stimulator or not, thus the patient was provided with medication.
 
Manufacturer Narrative
Additional information was received that the patient was experiencing vibration issues on her entire body and believed that it was due to malfunction of the ipg.The physicians all agreed that the vibration was not due to the ipg.Database analysis revealed no anomalies and the device appeared to be working as expected.The patient will undergo an explant procedure.
 
Event Description
A report was received that the patient was hospitalized due to spiking blood pressure and tremors in the hands.It was also reported that the patient was getting stimulation in the head and neck even when the stimulator was off.The physician's in the hospital did not confirm whether it was caused by the stimulator or not, thus the patient was provided with medication.
 
Manufacturer Narrative
Additional information was received that the patient underwent an explant procedure.It was further clarified that the physician did not suspect a device malfunction.Additional suspect medical device components involved in the event: model #: sc-2218-50 serial #: (b)(4), description: linear st lead, 50cm model #: sc-4318, lot #: 18338761 description: clik x anchor.
 
Event Description
A report was received that the patient was hospitalized due to spiking blood pressure and tremors in the hands.It was also reported that the patient was getting stimulation in the head and neck even when the stimulator was off.The physician's in the hospital did not confirm whether it was caused by the stimulator or not, thus the patient was provided with medication.
 
Manufacturer Narrative
Sc-1132 (sn: (b)(4)) device evaluation indicated that the ipg passed all tests performed.Sc-2218-50 (sn: (b)(4)) device evaluation indicated that the leads passed all tests performed.Sc-4318 (ln: 18338761) device evaluation indicated that visual inspection found that the clik anchor had one torn eyelet.There was no missing silicone.
 
Event Description
A report was received that the patient was hospitalized due to spiking blood pressure and tremors in the hands.It was also reported that the patient was getting stimulation in the head and neck even when the stimulator was off.The physician's in the hospital did not confirm whether it was caused by the stimulator or not, thus the patient was provided with medication.
 
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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 Key6226696
MDR Text Key63977871
Report Number3006630150-2017-00027
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821526
UDI-Public(01)08714729821526(17)180105(10)18764678
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,Followup,Followup
Report Date 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/05/2018
Device Model NumberSC-1132
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2016
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 Outcome(s) Hospitalization; Required Intervention;
Patient Age80 YR
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