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

Model Number SC-1200

Device Problem Material Separation (1562)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation indicated that the complaint was confirmed.The setscrew from port c was missing.It was reported that the setscrew fell out of ipg in the operation room when the tech was trying to lessen for port plug.The device functionality test was performed to ensure the device integrity.No other anomalies were found.

Event Description

A report was received that the product was return due to a setscrew fell out of ipg while the tech was trying to lessen for port plug.It was unknown if the missing setscrew was removed or left inside the patient's body.

Manufacturer Narrative

Additional information was received that the setscrew fell on the ground and was never near the patient's body.

Event Description

A report was received that the product was returned due to a setscrew fell out of ipg while the tech was trying to lessen for port plug.It was unknown if the missing setscrew was removed or left inside the patient's body.

• 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: 7432960
• MDR Text Key: 105557464
• Report Number: 3006630150-2018-01203
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729905943
• UDI-Public: 08714729905943
• 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: 05/29/2018

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 Date: 12/13/2019
• Device Model Number: SC-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2017
• 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: 75 YR