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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-8216-70
Device Problems Fracture (1260); Material Frayed (1262); Migration or Expulsion of Device (1395); Cut In Material (2454); Device Dislodged or Dislocated (2923)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
A report was received that the patient¿s lead appeared to be fractured with five contacts fallen off.It was also noted that the lead had migrated.The patient underwent a revision procedure wherein the lead was replaced.All fallen contacts were removed from the patient¿s body.The patient was reportedly doing well.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A report was received that the patient¿s lead appeared to be fractured with five contacts fallen off.It was also noted that the lead had migrated.The patient underwent a revision procedure wherein the lead was replaced.All fallen contacts were removed from the patient¿s body.The patient was reportedly doing well.
 
Manufacturer Narrative
Device evaluation indicated that the five distal electrodes of the lead were completely dislodged from the lead silicone, and not returned.Also, the right pigtail was frayed where the multi lumen outer tubing would meet the lead silicone, and was cut approximately one inch from the proximal end.The retention sleeve of the left pigtail was crushed by surgical tool(s).There were exposed cables.
 
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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 Key4836289
MDR Text Key5935500
Report Number3006630150-2015-01490
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 03/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/31/2012
Device Model NumberSC-8216-70
Other Device ID NumberM365SC8216700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2010
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;
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