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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-2316-70
Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/17/2015
Event Type  Injury  
Event Description
A report was received that the patient had loss of stimulation.The physician suspected that the leads or splitter might be fractured due to high impedances.It was also reported that the leads or splitters were suspected to be fractured before the surgery.The patient underwent a procedure wherein the leads, splitters and clik anchors were replaced.The patient was reportedly doing well post operatively.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-2316-70, serial/lot #: (b)(4), description: infinion 70 cm lead kit; model #: sc-3400-30, serial/lot #: (b)(4), description: infinion splitter 2x8 kit (30 cm); model #: sc-4316, serial/lot #: (b)(4), description: next generation anchor kit-sterile.Sc-2316-70 (sn (b)(4)) the complaint was confirmed.The infinion lead body was fractured at the bent/kinked section of the lead body, 1 cm from the click anchor set screw marks.There were no exposed cables.There are 10 cable fractures.Sc-2316-70 (sn (b)(4)) the complaint was confirmed.The infinion lead body was fractured at the bent/kinked section of the lead body, 1 cm from the click anchor set screw marks.There were no exposed cables.There are 12 cable fractures.Sc- 3400-30 (sn (b)(4)) device evaluation indicated that the splitter passed visual, electrical and photographic imaging tests performed.Both splitters exhibited no anomalies.Sc-4316 (ln 16611054) each clik anchor has a damaged eyelet with missing silicon.
 
Manufacturer Narrative
Additional information was received that the physician removed each eyelet with a fixate stitch and nothing was left inside the patient¿s body.
 
Event Description
A report was received that the patient had loss of stimulation.The physician suspected that the leads or splitter might be fractured due to high impedances.It was also reported that the leads or splitters were suspected to be fractured before the surgery.The patient underwent a procedure wherein the leads, splitters and clik anchors were replaced.The patient was reportedly doing well post operatively.
 
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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 Key4975852
MDR Text Key17845372
Report Number3006630150-2015-01970
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,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/31/2016
Device Model NumberSC-2316-70
Other Device ID NumberM365SC2316700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/17/2015
Initial Date FDA Received08/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2014
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 Age40 YR
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