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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 Incontinence (1928); Weakness (2145); Numbness (2415); Blood Loss (2597)
Event Date 11/06/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: model number/catalog number:sc-2218-50e; serial number: (b)(4); batch/lot number: 7071162; model/catalog description:linear st trial lead kit 50 cm. 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 medwatch will be filed.
 
Event Description
A report was received that following a trial procedure the patient had bleeding in the bandage site and the dressing was saturated with blood. It was also reported that the patient went to emergency room (er) due to weakness, numbness in legs and loss of bladder function. The physician believed that the symptoms were not device related. The patient underwent an early lead pull and was doing well.
 
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Brand NameINFINION 16
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
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key9387350
MDR Text Key168434764
Report Number3006630150-2019-06867
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 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC-2316-50E
Device Catalogue NumberSC-2316-50E
Device Lot Number7071057
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 Received11/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2019
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: 11/27/2019 Patient Sequence Number: 1
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