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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-2158-50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Nerve Damage (1979)
Event Date 01/10/2017
Event Type  Injury  
Event Description
A report was received that the patient had suffered sciatic nerve damage.It was noted that it was implanted twice.The first one was not set right and the wires fell down out of place.They place clamps on the second one and turn up so high to relieve the pain.The patient underwent an explant procedure.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-1110-02 serial #: (b)(4), description: precision implantable pulse generator (ipg); model #: sc-2158-50, serial #: (b)(4), description: linear lead with enhanced stylet, 50cm.
 
Event Description
A report was received that the patient posted on social media that she is still suffering with nerve damage to her sciatic nerve.The patient stated she underwent two implant procedures and she felt that during the first procedure the leads migrated down were not in the right position.The patient stated that to relieve the pain she had to turn it up so high that she was jump walking, and later underwent an explant procedure.
 
Manufacturer Narrative
Additional information was received that no further information could be obtained by the bsn representative.
 
Event Description
A report was received that the patient posted on social media that she is still suffering with nerve damage to her sciatic nerve.The patient stated she underwent two implant procedures and she felt that during the first procedure the leads migrated down were not in the right position.The patient stated that to relieve the pain she had to turn it up so high that she was jump walking, and later underwent an explant procedure.
 
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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 Key6271981
MDR Text Key65564038
Report Number3006630150-2017-00232
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 01/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/01/2012
Device Model NumberSC-2158-50
Was Device Available for Evaluation? No
Date Manufacturer Received05/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2010
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;
Patient Age70 YR
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