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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 Problems High impedance (1291); Difficult to Insert (1316)
Patient Problem No Code Available (3191)
Event Date 12/16/2020
Event Type  Injury  
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event. Additional suspect medical device component involved in the event: product family: scs-linear leads; upn: m365sc2218500; model: sc-2218-50; serial: (b)(4); batch: 16634227.
 
Event Description
It was reported that the patients leads had high impedances. It was also stated that the physician had a hard time connecting the lead with the battery. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted devices were not returned.
 
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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)
BOSTON SCIENTIFIC CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key11121581
MDR Text Key225252586
Report Number3006630150-2020-06575
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
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/06/2016
Device Model NumberSC-2218-50
Device Catalogue NumberSC-2218-50
Device Lot Number16634227
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 Received12/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2014
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: 01/05/2021 Patient Sequence Number: 1
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