MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORP. SCS SPINAL CORD STIMULATOR; STIMULATOR SPINAL CORD TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1160

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2019

Event Type  malfunction  

Event Description

Scs stopped working last year in august, had new unit surgically implanted.Stopped working again 2 weeks ago.Company non responsive.This is the second time in less than a year that the scs unit has gone dead.Company again is dragging its feet in getting unit replaced.

• Brand Name: SCS SPINAL CORD STIMULATOR
• Type of Device: STIMULATOR SPINAL CORD TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORP. ; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8723632
• MDR Text Key: 149084993
• Report Number: MW5087536
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/06/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC-1160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 89