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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 Fracture (1260); Device, or device fragments remain in patient (1527); Material Separation (1562); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/03/2014
Event Type  Injury  
Event Description
A report was received that a piece of the patient¿s trial lead sheared off inside the body.The top five contacts fragmented off and remained inside the patient¿s body.The patient was reportedly doing well.The lead is not being removed.
 
Manufacturer Narrative
Device evaluation indicated that the top five electrodes of the lead were separated from the distal end.The electrodes were not returned.It appeared that tensile force was applied on the top five electrodes resulting in fractured cable welds and its separation from the distal end.The root cause of the damage was unknown.
 
Event Description
A report was received that a piece of the patient¿s trial lead sheared off inside the body.The top five contacts fragmented off and remained inside the patient¿s body.The patient was reportedly doing well.The lead is not being removed.
 
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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 Key3898557
MDR Text Key16856210
Report Number3006630150-2014-01438
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
Report Date 06/03/2014
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 Date04/23/2016
Device Model NumberSC-2316-50E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/10/2014
Initial Date FDA Received06/26/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/01/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2014
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 Age48 YR
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