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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2352-70
Device Problems Difficult to Insert (1316); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2021
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-lead fixation, upn: (b)(4), model: sc-4318, serial: na, batch: 25906221.
 
Event Description
It was reported that after a permanent trial, the patient underwent a permanent ipg implant procedure. During the implant procedure, the patient's lead was bent at the connector due to an unknown reason and could not be inserted into the ipg. The lead and clik anchor were explanted and replaced. The patient was doing well postoperatively.
 
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Brand NameLINEAR 3-4
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
road 698, lot no. 12
dorado PR 00646 -260
00646-2602
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key11530662
MDR Text Key241103384
Report Number3006630150-2021-01102
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC-2352-70
Device Catalogue NumberSC-2352-70
Device Lot Number7071127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2020
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: 03/19/2021 Patient Sequence Number: 1
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