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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 Problem Migration (4003)
Patient Problems Bacterial Infection (1735); Pneumonia (2011); Pocket Erosion (2013); Sepsis (2067); No Code Available (3191)
Event Date 02/11/2020
Event Type  Injury  
Manufacturer Narrative
Model number/catalog number: sc-2352-70, serial number: (b)(4), batch/lot number: 17458557/17458557, model/catalog description: linear 3-4 lead 70 cm.
 
Event Description
A report was received that the patients ipg seemed to be shallowing and exiting the skin. It was also noted that the patient was hospitalized for sepsis, flu and pneumonia. The physician believed that the device may be infected and prescribed the patient with oral antibiotics.
 
Manufacturer Narrative
Additional information was received that the patient underwent an explant procedure. The explanted devices were not returned to bsn as they were kept by the medical facility.
 
Event Description
A report was received that the patients ipg seemed to be shallowing and exiting the skin. It was also noted that the patient was hospitalized for sepsis, flu and pneumonia. The physician believed that the device may be infected and prescribed the patient with oral antibiotics.
 
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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 CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key9832788
MDR Text Key183471815
Report Number3006630150-2020-01186
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
Report Date 04/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/15/2016
Device Model NumberSC-1132
Device Catalogue NumberSC-1132
Device Lot Number17530666
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 Received03/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2014
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: 03/14/2020 Patient Sequence Number: 1
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