MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

Device Problem Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain patient weight, and but it was not received.

Event Description

It was reported that the ipg failed to establish communication with external devices.The ipg was deemed inoperable and patient lost therapy.Surgery may occur later to address the issue.

Manufacturer Narrative

An inoperable ipg was reported to abbott.The device was not returned for analysis; however, the implant data log was received.Analysis of the record shows that the system is in service app mode and not delivering therapy.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.Actions have been taken to prevent reoccurrence.A new ipg was implanted to restore therapy.

Event Description

Additional information was received indicating the ipg was replaced to address this issue.

• Brand Name: PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15161818
• MDR Text Key: 297208395
• Report Number: 1627487-2022-03822
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067031419
• UDI-Public: 05415067031419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 7709710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS ANCHORS (X2); SCS LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 64 KG