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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION INFINION 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION INFINION 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2316-50E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Itching Sensation (1943); Nausea (1970); Pain (1994); Burning Sensation (2146)
Event Date 04/18/2019
Event Type  Injury  
Manufacturer Narrative
Model number/catalog number: sc-2316-50e.(b)(4).Model/catalog description: infinion 16 trial lead kit 50 cm.The explanted devices were not returned to bsn as they were discarded by the medical facility.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
 
Event Description
A report was received that the patient could not barely move or walk due to having pain.It was also reported that the patient was being nauseated, had a headache and was getting undesired stimulation at the leg.The patient had lost bladder function and the patient was experiencing burning sensation and itchiness due to having an allergy from the mastisol.The physician believed that the patients pain was due to the allergic reaction from the mastisol.The patient underwent an early lead pull procedure and was prescribed with medication.
 
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Brand Name
INFINION 16
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)
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 Key8587142
MDR Text Key144294238
Report Number3006630150-2019-02111
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729797807
UDI-Public08714729797807
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 Physician
Type of Report Initial
Report Date 05/07/2019
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 Date02/25/2021
Device Model NumberSC-2316-50E
Device Catalogue NumberSC-2316-50E
Device Lot Number5130990
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/18/2019
Initial Date FDA Received05/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2019
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 Age37 YR
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