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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION®; STIMULATOR SPINAL CORD
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION®; STIMULATOR SPINAL CORD Back to Search Results
Model Number SC-2218-70
Device Problems Break (1069); High impedance (1291); Cut In Material (2454); Positioning Problem (3009)
Patient Problem Inadequate Pain Relief (2388)
Event Date 10/07/2014
Event Type  Injury  
Event Description
A report was received that the patient was experiencing loss of stimulation; the leads had high impedances and the scs was not working after a non-device related surgery.X-ray showed a broken lead.The patient will undergo a replacement.It was also reported that the patient will undergo a revision where the ipg will be moved for unknown reason.
 
Event Description
A report was received that the patient was experiencing loss of stimulation; the leads had high impedances and the scs was not working after a non-device related surgery.X-ray showed a broken lead.The patient will undergo a replacement.It was also reported that the patient will undergo a revision where the ipg will be moved for unknown reason.
 
Manufacturer Narrative
Additional information was received that no further course of action will be taken.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
 
Manufacturer Narrative
Additional information was received that the patient will undergo a procedure wherein one of the patient¿s system will be entirely replaced with a new one.
 
Event Description
A report was received that the patient was experiencing loss of stimulation; the leads had high impedances and the scs was not working after a non-device related surgery.X-ray showed a broken lead.The patient will undergo a replacement.It was also reported that the patient will undergo a revision where the ipg will be moved for unknown reason.
 
Manufacturer Narrative
Additional information was received that the patient will undergo a revision due to lead malfunction.
 
Event Description
A report was received that the patient was experiencing loss of stimulation; the leads had high impedances and the scs was not working after a non-device related surgery.X-ray showed a broken lead.The patient will undergo a replacement.It was also reported that the patient will undergo a revision where the ipg will be moved for unknown reason.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: model#: sc-2218-70, serial #: (b)(4), description: linear st lead, 50cm.Model#: sc-1110-02, serial #: (b)(4), description: precision implantable pulse generator (ipg).
 
Event Description
A report was received that the patient was experiencing loss of stimulation; the leads had high impedances and the scs was not working after a non-device related surgery.X-ray showed a broken lead.The patient will undergo a replacement.It was also reported that the patient will undergo a revision where the ipg will be moved for unknown reason.
 
Manufacturer Narrative
Additional information was received that the physician was able to confirm that the high impedances were due to the leads that were severed or cut to what was presumed during the patient¿s non device related procedure and not anything to do with the generator.The patient underwent a procedure wherein the whole entire system was replaced per physician's preference.The explanted devices were not returned to bsn as they were discarded by the medical facility.
 
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Brand Name
PRECISION®
Type of Device
STIMULATOR SPINAL CORD
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 Key4477158
MDR Text Key5740663
Report Number3006630150-2015-00260
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
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/01/2015
Device Model NumberSC-2218-70
Other Device ID NumberM365SC2218700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2013
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 Age39 YR
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