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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 Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiopulmonary Arrest (1765); Stroke/CVA (1770); Unspecified Infection (1930); Paralysis (1997); Seizures (2063); Sepsis (2067); Coma (2417); No Code Available (3191)
Event Date 06/06/2017
Event Type  Injury  
Manufacturer Narrative
Explant date: approximately (b)(6) 2017.
 
Event Description
A report was received that the patient claims that approximately four years after being implanted she was hospitalized and in a coma for 55 days, and had four blood transfusions while on life support. During this time the patients heart stopped and a temporary pacemaker was implanted. The patient also reported that she developed methicillin-resistant (b)(6) , meningitis, and sepsis. The patient underwent an explant procedure and received iv vancomycin for six months for infection. In addition, she stated she was bed ridden and spent six months in a nursing home. Due to the scar tissue that resulted from the infection, the patient now has lost that ability to move and has difficulty walking and sleeping. Patient also has hearing and memory loss.
 
Manufacturer Narrative
(b)(6). Additional information received: physician does not think that the infection was device related as the patient was septic. All devices have been explanted and nothing will be returned. He further states that the implanted device was not helping with her pain. Additional suspect medical device components involved in the event: model: sc-4316, serial/lot: (b)(4), description: clik anchor. Model: sc-8216-70, serial/lot: (b)(4), description: artisan lead 70cm. As the device involved in the complaint has not been returned, the complaint investigation site (cis) could not perform a device analysis. However, a review of the complaint report, device history record, and sterilization record were found to be satisfactory and did not find any anomalies or deviations that potentially relate to the reported event; there is no reason to suspect a manufacturing defect as the source of the reported complaint. Explant date: approximately (b)(6) 2017.
 
Event Description
A report was received that the patient claims that approximately four years after being implanted she was hospitalized and in a coma for 55 days, and had four blood transfusions while on life support. During this time the patients heart stopped and a temporary pacemaker was implanted. The patient also reported that she developed (b)(6), meningitis, and sepsis. The patient underwent an explant procedure and received iv vancomycin for six months for infection. In addition, she stated she was bed ridden and spent six months in a nursing home. Due to the scar tissue that resulted from the infection, the patient now has lost that ability to move and has difficulty walking and sleeping. Patient also has hearing and memory loss.
 
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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
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key7886947
MDR Text Key120643944
Report Number3006630150-2018-60936
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,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/04/2015
Device Model NumberSC-1132
Device Catalogue NumberSC-1132
Device Lot Number16493193
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 Received05/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2013
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: 09/18/2018 Patient Sequence Number: 1
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