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

Model Number 3662

Device Problems Battery Problem (2885); No Apparent Adverse Event (3189)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2023

Event Type  Injury  

Manufacturer Narrative

Event date is estimated.

Event Description

It was reported the patient¿s ipg had received an end of life message.A manufacturer representative confirmed the issue and the ipg deemed inoperable.Surgical intervention may be taken at a later date to address the issue.

Manufacturer Narrative

The ipg was determined to be no longer reportable at this time due to the ipg functioning for the expected timeframe/ longevity.

Event Description

Additional information was received indicating that the patients ipg was still operable prior to surgery and therefore met its expected longevity.

• 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: 16272343
• MDR Text Key: 308476811
• Report Number: 1627487-2023-00439
• 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
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

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: 03/08/2019
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 5887525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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 LEAD; SCS LEAD ANCHOR (X2)
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female