MAUDE Adverse Event Report: ABBOTT MEDICAL CHARGING SYSTEM RECHARGEABLE IPG; SCS CHARGER

Model Number 3701

Device Problem Temperature Problem (3022)

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

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Date of event and therapy date are estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-48302.It was reported that the pocket site was heating up when the patient attempted to charge.As a result, surgery may occur to address the issue.The patient also had an inoperable ipg, documented in manufacturer reference number: 1627487-2020-48010.

Manufacturer Narrative

A patient experiencing pocket heating at the ipg site while attempting to recharge was reported to abbott.The patient had not attempted to charger in over 5 years.As a result, the ipg was replaced and therapy was restored.It has been determined that excessive heating during charging of the eon ipgs can occur at the pocket site when using the older generation eon ipg chargers models 3701 and 3711.

• Brand Name: CHARGING SYSTEM RECHARGEABLE IPG
• Type of Device: SCS CHARGER
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10932228
• MDR Text Key: 219115935
• Report Number: 1627487-2020-48301
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402477
• UDI-Public: 05414734402477
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 3701
• Device Catalogue Number: 3701
• Device Lot Number: 3528826
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/07/26/2012/001-C
• Patient Sequence Number: 1
• Treatment: SCS IPG; SCS IPG
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 86