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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPINAL CORD STIMULATOR

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-2218-70
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Reaction (2414); Skin Inflammation (2443)
Event Date 01/19/2017
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-2218-70, serial # (b)(4), description: linear st lead, 70cm.
 
Event Description
A report was received that the patient went to the emergency room due to their surgical wound being very red. The physician believed that the patient's symptom was due to a rejection of their implanted devices.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: model # sc-2218-70 serial/lot # 3022533 description: linear st lead, 70cm additional information was received that the wound continues with granuloma. The physician assessed that the granuloma is related with the leads because the problem has always been in the wound of the leads. The patient will undergo a revision procedure and if after that, it does not improve, the physician will explant the system.
 
Event Description
A report was received that the patient went to the emergency room due to their surgical wound being very red. The physician believed that the patient's symptom was due to a rejection of their implanted devices.
 
Manufacturer Narrative
Additional information was received that the physician removed the granuloma and performed surgical wound remodeling on (b)(6) 2017. There was nothing replaced or added. The patient is reportedly doing good following the procedure. It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed. A review of the device history records will be conducted. If there is any further relevant information from that review, a supplemental med watch will be filed.
 
Event Description
A report was received that the patient went to the emergency room due to their surgical wound being very red. The physician believed that the patient's symptom was due to a rejection of their implanted devices.
 
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Brand NamePRECISION
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 Key6314218
MDR Text Key66914311
Report Number3006630150-2017-00451
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/19/2017
Device Model NumberSC-2218-70
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 Received04/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2015
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: 02/09/2017 Patient Sequence Number: 1
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