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

Model Number SC-1132

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

Patient Problems Abscess (1690); Pain (1994); Scar Tissue (2060)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2218-70, serial #: (b)(4), description: linear st lead, 70 cm.

Event Description

A report was received that the patient was experiencing chest pain and had to go to the emergency room (er).It was believed that the cause of chest pain was an abscess, which was near the patient's implant site on the chest area.It was unknown if there was any intervention given in the er.The er physician confirmed that there was no visible damage or leakage from scs device.

Manufacturer Narrative

Additional information was received that the patient was having issues with scar tissue and was not complaining about the abscess.The patient was experiencing a new pain in the shoulder that was not device related.The patient does not want the device removed as the physician confirmed that everything with the device was good.

Event Description

A report was received that the patient was experiencing chest pain and had to go to the emergency room (er).It was believed that the cause of chest pain was an abscess, which was near the patients implant site on the chest area.It was unknown if there was any intervention given in the er.The er physician confirmed that there was no visible damage or leakage from scs device.

• Brand Name: PRECISION SPECTRA
• 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: 7300564
• MDR Text Key: 101077932
• Report Number: 3006630150-2018-00739
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• 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: 04/18/2018

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: 10/25/2018
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2016
• 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: 50 YR