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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2218-50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 09/06/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: model number/catalog number: sc-2218-50, serial number: (b)(4), batch/lot number: 21215472, model/catalog description: linear st lead kit 50 cm.
 
Event Description
A report was received that the patient had an infection. Symptom of abscess was noted at the lead site.
 
Manufacturer Narrative
A review of the manufacturing documentation for the leads revealed that no anomalies or deviations potentially related to the event occurred during manufacturing. A review of the sterilization documentation for the device(s) was found to be satisfactory.
 
Event Description
A report was received that the patient had an infection. Symptom of abscess was noted at the lead site.
 
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Brand NameLINEAR ST
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)
GUIDANT PUERTO RICO, B.V.
no. 12, road 698
,
dorado PR 00646 3311
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key7928385
MDR Text Key122445917
Report Number3006630150-2018-61159
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 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/09/2019
Device Model NumberSC-2218-50
Device Catalogue NumberSC-2218-50
Device Lot Number21215472
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 Received10/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2017
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: 10/02/2018 Patient Sequence Number: 1
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