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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-2316-50E
Device Problems Break (1069); Material Separation (1562); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2018
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: model#: sc-2316-50e serial #: (b)(4) description: infinion 1x16 perc lead and splitter 2x8 kits the explanted devices were not returned to bsn as they were discarded by the medical facility.A review of the manufacturing documentation for the leads revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
 
Event Description
A report was received that during the removal of the trial leads, the lead broke and contacts were missing.X-rays were taken and confirmed that the contacts were no longer in the epidural space but were present superficially.The patient underwent a procedure to remove the remainder of the leads and was verified through x-ray that everything was removed.The patient was reportedly doing well.
 
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Brand Name
PRECISION
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 Key7504799
MDR Text Key107954615
Report Number3006630150-2018-01652
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729797807
UDI-Public08714729797807
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
Report Date 05/10/2018
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? No
Device Operator Lay User/Patient
Device Expiration Date01/31/2020
Device Model NumberSC-2316-50E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/18/2018
Initial Date FDA Received05/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2018
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 Age56 YR
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