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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1200
Device Problems Unexpected Therapeutic Results (1631); Migration (4003)
Patient Problems Pain (1994); Discomfort (2330); Inadequate Pain Relief (2388)
Event Date 03/02/2022
Event Type  Injury  
Manufacturer Narrative
Date of event: exact date unknown, event occurred a day before the manufacturer was made aware.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218500, model: sc-2218-50, serial: (b)(4), batch: 7083400/7083514.Product family: scs-linear leads, upn: m365sc2218700, model: sc-2218-70, serial: (b)(4), batch: 5037938/7070019.
 
Event Description
It was reported that the patient was experiencing persistent pain and discomfort at the ipg site.Inadequate stimulation was also reported.The patient was prescribed with pain medications.
 
Event Description
It was reported that the patient was experiencing persistent pain and discomfort at the ipg site.Inadequate stimulation was also reported.The patient was prescribed with pain medications.Additional information was received that the leads had migrated and was confirmed via x-ray.All components were explanted and will not be returned per hospital policy.
 
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Brand Name
PRECISION MONTAGE MRI
Type of Device
STIMULATOR, 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
cashel road
clonmel
EI  
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key13825289
MDR Text Key287529745
Report Number3006630150-2022-01107
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729905943
UDI-Public08714729905943
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/26/2021
Device Model NumberSC-1200
Device Catalogue NumberSC-1200
Device Lot Number366301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/03/2022
Initial Date FDA Received03/19/2022
Supplement Dates Manufacturer Received09/18/2023
Supplement Dates FDA Received10/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age48 YR
Patient SexFemale
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