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

Model Number SC-2316-50E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Dizziness (2194); Sweating (2444); Fluid Discharge (2686); No Code Available (3191)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

Model number/catalog number: sc-2316-50e, serial number: (b)(4), batch/lot number: 5136561, 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.A review of the manufacturing documentation for the leads revealed that no anomalies or deviations potentially relate to the event occurred during manufacturing.A review of the sterilization documentation for the devices were found to be satisfactory.

Event Description

A report was received that a trial patient had an infection and was experiencing pain at the lead site along with cold sweats and lightheadedness.Symptom of infection was a white cloudy drainage on both lead sites.The patient underwent a lead pull procedure and the lead site was cleaned and drainage was removed.The physician believed that infection was not device related and the cause was unknown.The patient was placed on intravenous antibiotics.

• 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 Key: 8759996
• MDR Text Key: 150004249
• Report Number: 3006630150-2019-03248
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: 08714729797807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/18/2021
• Device Model Number: SC-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 5136503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR