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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-2218-70
Device Problem High impedance (1291)
Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)
Event Date 01/22/2019
Event Type  Injury  
Manufacturer Narrative

Model number/catalog number: sc-2218-70, serial number: (b)(4), batch/lot number: 14914930, model/catalog description: linear st lead kit 70 cm. Model number/catalog number: sc-1110-02, serial number: (b)(4), batch/lot number: 15017355, model/catalog description: precision ipg kit.

 
Event Description

A report was received that the patient was experiencing severe pain near the mid thoracic area at the right of the spine. The patient was admitted to the hospital and was diagnosed with having a lipoma. Impedances were checked and found that there were high impedances on patients leads. The physician could not determine what was causing the patients new pain area. It was also noted that the patient had a history of cancer. The patient will undergo an explant procedure.

 
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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 Key8348136
MDR Text Key136468485
Report Number3006630150-2019-00619
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/01/2014
Device MODEL NumberSC-2218-70
Device Catalogue NumberSC-2218-70
Device LOT Number14970638
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 Received01/29/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/06/2012
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: 02/18/2019 Patient Sequence Number: 1
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