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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 Problems Fracture (1260); Use of Device Problem (1670); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 07/21/2021
Event Type  Injury  
Event Description
It was reported that during the trial procedure the physician could not get the lead into the epidural space so the trial was aborted. The physician decided to do a blood patch as he seemingly wet tapped the patient. While doing the blood patch, the physician decided to try to get the lead in however, it was not a good idea to reinsert lead at the steep of an angle. The physician pulled the lead back, however it was really difficult and frayed the end of the lead. It was confirmed through x-ray that ten of the sixteen contacts were remained in the patient, and the patient was sent to er (emergency room), and the surgeon removed the lead. The patient has been admitted, resting and healing in the hospital.
 
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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
00646-2602
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12312819
MDR Text Key266200961
Report Number3006630150-2021-04473
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,Followup
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC-2316-50E
Device Catalogue NumberSC-2316-50E
Device Lot Number7126414
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 Received08/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/12/2021 Patient Sequence Number: 1
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