MAUDE Adverse Event Report: ABBOTT MEDICAL; STIMULATOR, SPINAL-CORD

Model Number 3662

Device Problems Migration or Expulsion of Device (1395); Battery Problem (2885)

Patient Problems Erythema (1840); Inflammation (1932); Pain (1994)

Event Date 03/28/2019

Event Type  malfunction  

Event Description

The patient had replacement of a spinal cord stimulator system.On post-op follow-up, the patient noted the battery appeared to be shifting into "an uncomfortable sideways" position which caused him pain and intermittent redness around the incisional area.When the implantable pulse generator (ipg) was replaced (this surgery) and repositioned to a new pocket, the intraoperative check showed a battery failure.This was an outpatient surgery and the patient was discharged home that day.

• Type of Device: STIMULATOR, SPINAL-CORD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 8627003
• MDR Text Key: 145628183
• Report Number: 8627003
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/03/2019,04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3662
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2019
• Device Age: 2 MO
• Date Report to Manufacturer: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA