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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-1132
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Bacterial Infection (1735); Fever (1858); Unspecified Infection (1930); Impaired Healing (2378)
Event Date 12/12/2017
Event Type  Injury  
Manufacturer Narrative
Additional information was received that the patients infection was at the pocket site. Symptoms of fever and impaired wound healing were noted. The physician believed that the infection was not device or procedure related. The patient was prescribed antibiotics and underwent explant of ipg and two leads. Additional suspect medical device components involved in the event: model #: sc-2352-50 serial #: (b)(4) description: linear 3-4 lead, 50cm the explanted devices were not returned to bsn. A review of the manufacturing documentation for the ipg and leads revealed that no anomalies or deviations potentially related to the event occurred during manufacturing. A review of the sterilization documentation for the devices was found to be satisfactory.
 
Event Description
A report was received that the patient had an infection. The patient underwent an ipg explant procedure.
 
Manufacturer Narrative
Additional information was received that device malfunction was not suspected and the patient was reportedly doing well.
 
Event Description
A report was received that the patient had an infection. The patient underwent an ipg explant procedure.
 
Event Description
A report was received that the patient had an infection. The patient underwent an ipg explant procedure.
 
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Brand NamePRECISION SPECTRA
Type of DeviceSPINAL 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 Key7153207
MDR Text Key106286388
Report Number3006630150-2017-05299
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/08/2019
Device Model NumberSC-1132
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 Received02/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2017
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: 12/28/2017 Patient Sequence Number: 1
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