MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; SPINAL CORD STIMULATOR

Model Number SC-2408-56

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

Patient Problem Respiratory Distress (2045)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-2408-56, serial#: (b)(4), description: avista mri perc lead kit, 56 cm.Model#: sc-4319, lot#: 21831182, description: clik x mri anchor.The explanted devices were not returned to bsn as they were kept by the medical facility.

Event Description

A report was received that during an implant procedure when they were about to tunnel the pocket, the patient had airway issues.The patients procedure was aborted and the leads and anchors were explanted.

Manufacturer Narrative

Sc-1200 (sn: (b)(4)) device evaluation indicated that the reported complaint states that a case was aborted because the patient exhibited other medical condition.The ipg was opened but not implanted.No analysis is required; there is no alleged failure on returned ipg.

Event Description

A report was received that during an implant procedure when they were about to tunnel the pocket, the patient had airway issues.The patient's procedure was aborted and the leads and anchors were explanted.

• Brand Name: PRECISION MONTAGE MRI
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7580425
• MDR Text Key: 110444403
• Report Number: 3006630150-2018-02053
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729904816
• UDI-Public: 08714729904816
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• 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,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/13/2020
• Device Model Number: SC-2408-56
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• 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: 57 YR