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

Model Number SC-5532-1

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

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Inadequate Pain Relief (2388); Reaction (2414); Numbness (2415); Weight Changes (2607)

Event Date 05/25/2016

Event Type  Injury  

Event Description

I had the spinal cord stimulator implanted in my body on (b)(6) 2016.Right next day, (b)(6) 2016 , i woke up with huge rashes and itching all over my body, inside my mouth and over my eyes.Too much pain in my legs, feet and hands like having too much pressure.Lost very good amount of weight.Before this surgery i was about (b)(6), and after surgery i am (b)(6).Very sharp and strong pain in my right side of head where the area is still numb after 1 days of surgery.Today it will be 73 days and still i am having same issues and it's getting worse even the device is off for 48 days.Any medication makes my condition worst, but i had to take janumet to control my sugar.

• Brand Name: PRECISION SPECTRA
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5865464
• MDR Text Key: 51840484
• Report Number: MW5063971
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821595
• UDI-Public: (01)08714729821595
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/05/2016

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 Model Number: SC-5532-1
• Device Lot Number: 19104769
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 66