MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3662

Device Problem Wireless Communication Problem (3283)

Patient Problem Failure of Implant (1924)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported that the patient's ipg has consistent communication issues while trying to connect to external devices.A manufacturer representative met with the patient and attempted to connect multiple times, but the ipg would not hold a bond for long.As a result, surgical intervention may take place at a later date to address the issue.

Event Description

Additional information received stated that the patient underwent surgical intervention wherein the ipg was explanted and replaced.Post-operatively, stimulation therapy was restored and the communication issues were resolved.

Manufacturer Narrative

A4 patient weight added to the report.

Manufacturer Narrative

The reported observation ¿multiple error messages during cp/pc communication¿ was confirmed and duplicated during analysis.The root cause of the observation was due to the bluetooth (ble) antenna electrical contacts not being properly seated into the hybrid plug p2 of the printed circuit board.The ipg diagnostic logs from the field showed the bluetooth ¿ble¿ function did allow a communication session on the reported observation date.The ipg logs also showed the device had been programmed and stimulation was turned off and on.The device exhibited normal functionality during analysis when the device was in close proximity to an artemis programmer.As the distance between the returned ipg and artemis programmer increased, the ability to communicate was reduced, which is consistent with the field observation.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed with the tester bluetooth interface dongle positioned within 1ft of the returned ipg.Normal positioning of the bluetooth interface dongle is 6 ft from the ipg, but the returned ipg did not pass.Manufacturing investigation: plano site: no issue found with dhr review.There was no rework or ncmr associated with this event.

Manufacturer Narrative

The reported observation ¿multiple error messages during cp/pc communication¿ was confirmed and duplicated during analysis.The root cause of the observation was due to the bluetooth (ble) antenna leads were fractured at the header/can junction.The ipg diagnostic logs from the field showed the bluetooth ¿ble¿ function did allow a communication session on the reported observation date.The ipg logs also showed the device had been programmed and stimulation was turned off and on.The device exhibited normal functionality during analysis when the device was in close proximity to an artemis programmer.As the distance between the returned ipg and artemis programmer increased, the ability to communicate was reduced, which is consistent with the field observation.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed with the tester bluetooth interface dongle positioned within 1ft of the returned ipg.Normal positioning of the bluetooth interface dongle is 6 ft from the ipg, but the returned ipg failed at this distance.Manufacturing investigation: plano site: no issue found with dhr review.There was no rework or ncmr associated with this event.

• Brand Name: PROCLAIM¿ 7 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 11979533
• MDR Text Key: 255971438
• Report Number: 1627487-2021-14766
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020222
• UDI-Public: 05415067020222
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2024

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: 08/23/2020
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 6600086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 06/24/2021; 08/31/2021; 02/19/2024
• Supplement Dates FDA Received: 07/13/2021; 09/09/2021; 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• 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
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 100 KG