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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 Inoperable (1663); Defective Device (2588)
Patient Problems No Information (3190); No Code Available (3191)
Event Date 05/03/2018
Event Type  Injury  
Event Description
A report was received that the patients ipg was non-functional. The will undergo an explant procedure.
 
Manufacturer Narrative
Additional information was received that the patient was going on a lot of health issues thus wanted the scs devices removed. The patient needed cardiac clearance before scs can be removed. No further course of action will be taken at this time. A review of the manufacturing documentation for the device revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
 
Event Description
A report was received that the patients ipg was non-functional. The patient will undergo an explant procedure.
 
Manufacturer Narrative
Model number/catalog number: sc-8352-50, serial number: (b)(4), batch/lot number: 20346196, model/catalog description: coveredge x 32 surgical lead kit 50 cm. The explanted devices were not returned to bsn as they were kept by medical facility.
 
Event Description
A report was received that the patients ipg was non-functional. The patient will undergo an explant procedure.
 
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Brand NamePRECISION SPECTRA
Type of DeviceSTIMULATOR, 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 CA
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key7543195
MDR Text Key109228457
Report Number3006630150-2018-01791
Device Sequence Number1
Product Code LGW
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
Type of Report Initial,Followup,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/21/2018
Device Model NumberSC-1132
Device Catalogue NumberSC-1132
Device Lot Number19984447
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/24/2018 Patient Sequence Number: 1
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