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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1132
Device Problems Device Displays Incorrect Message (2591); Charging Problem (2892); Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 07/09/2018
Event Type  Injury  
Event Description
A report was received that the patient was having remote control (rc) connectivity issues.It was also reported that the patients battery was on sideways and causing pain.The patient will undergo an ipg relocation procedure.
 
Manufacturer Narrative
Additional information was received that database analysis revealed signs of poor charger to ipg coupling which prolonged charging times and ten magnet resets that occurred on unknown dates over the ipg lifetime.The patient underwent a revision procedure wherein the ipg was replaced and relocated.The patient was doing well postoperatively.
 
Event Description
A report was received that the patient was having remote control (rc) connectivity issues.It was also reported that the patients battery was on sideways and causing pain.The patient will undergo an ipg relocation procedure.
 
Manufacturer Narrative
Sc-1132 (sn(b)(4)).Device evaluation indicated that the returned ipg passed all the required tests and revealed no anomalies.
 
Event Description
A report was received that the patient was having remote control (rc) connectivity issues.It was also reported that the patients battery was on sideways and causing pain.The patient will undergo an ipg relocation procedure.
 
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Brand Name
PRECISION SPECTRA
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CLONMEL LIMITED
cashel road
,
clonmel
EI  
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key7744726
MDR Text Key115887484
Report Number3006630150-2018-60463
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821526
UDI-Public08714729821526
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/06/2019
Device Model NumberSC-1132
Device Catalogue NumberSC-1132
Device Lot Number21096153
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2017
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 Age35 YR
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