MAUDE Adverse Event Report: UNKNOWN SCS ALGOVITA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Device Problems Failure to Charge (1085); Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Caller reported they had a scs called algovita and had the scs implanted by dr.(b)(6) about 2 years ago.About 1-2 months ago, the recharger for the scs was getting hot to the touch and the pt had been having difficulty recharging their scs device.Pt said the cord coming from the outlet seems to be charging, but the other cord that the pt placed over the scs to charge the recharging device did not charge the scs.Pt said the external equipment got hot after charging for about 20-25 minutes(pt typically charged for about an hour).The patient was redirected to their healthcare provider to further address the issue.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SCS ALGOVITA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535172
• MDR Text Key: 321406187
• Report Number: MW5142071
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1