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 Inadequate Pain Relief (2388)

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event information.

Event Description

It was reported that the patient had an unrelated surgery on (b)(6) 2021 prior to which the ipg was not placed into surgery mode.Afterward, the ipg was unable to communicate with external device and patient lost therapy.Troubleshooting is pending.

Event Description

Additional information was received that troubleshooting resolved the issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Actions have been taken to prevent reoccurrence.

• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 13048387
• MDR Text Key: 282553946
• Report Number: 1627487-2021-19180
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2018
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 5450153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR; SCS LEAD (X2)
• Patient Sex: Male
• Patient Weight: 113 KG