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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1110-02
Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Discomfort (2330)
Event Date 07/01/2021
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc3138xx, model: sc-3138-xx, serial: unknown, batch: unknown.
 
Event Description
It was reported that the patient experienced pain, discomfort, and over stimulation at the ipg, implantable pulse generator, site. The patient also experienced inadequate stimulation and over stimulation when making postural changes which were caused by high impedances on the lead extension. Re-programming was attempted but was unsuccessful. The patient underwent a revision procedure in which the ipg and a lead extension were replaced. The patient is doing well post operatively and is happy with the stimulation coverage. The devices will not be returned as they were disposed of by the facility.
 
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Brand NamePRECISION
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 Key12530686
MDR Text Key273319332
Report Number3006630150-2021-05393
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeSW
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 10/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2013
Device Model NumberSC-1110-02
Device Catalogue NumberSC-1110-02
Device Lot Number14160124
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 Received09/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2011
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: 09/24/2021 Patient Sequence Number: 1
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