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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 Device Inoperable (1663); Low impedance (2285); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2018
Event Type  malfunction  
Event Description
A report was received that following a pocket revision procedure wherein the ipg pocket was deepened, the patients battery stopped working.The patient underwent an ipg replacement procedure.The patient was doing well postoperatively.
 
Manufacturer Narrative
Sc-1132 (sn: (b)(4)) device evaluation indicated that the reported complaint of ipg stopped working was confirmed.Upon receipt, the device was not functional, subsequently, the device was cut open and the internal inspection revealed excessive sleep current leakage.A hot spot was observed on the component (33.8°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.It was reported that the device may have damaged during a procedure to deepen the ipg pocket.
 
Event Description
A report was received that following a pocket revision procedure wherein the ipg pocket was deepened, the patients battery stopped working.The patient underwent an ipg replacement procedure.The patient was doing well postoperatively.
 
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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 Key7562189
MDR Text Key109834448
Report Number3006630150-2018-01889
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
Report Date 07/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/17/2016
Device Model NumberSC-1132
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/14/2018
Initial Date FDA Received06/01/2018
Supplement Dates Manufacturer Received06/13/2018
Supplement Dates FDA Received07/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2015
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 Age41 YR
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