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

Model Number	3701
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SCS CHARGER
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10932228
• Report Number: 1627487-2020-48301
• Device Sequence Number: 790862
• Product Code: LGW
• UDI-Device Identifier: 05414734402477
• UDI-Public: 05414734402477
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2020

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?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1627487/07/26/2012/001-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS IPG; SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Weight: 86