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

Model Number 3665

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 08/27/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Date of event is estimated.

Event Description

It was reported the ipg had reached end of life.In turn, the ipg was explanted and replaced to address the issue.

Manufacturer Narrative

The reported observation of ¿end of life ipg¿ was confirmed.The root cause of the reported observation was due to the device having normal battery depletion to the end of life (eol).The device provided therapy per the programming up to the eol declaration date.The device longevity by determining the energy factors over the implant period.The estimated longevity would have been 1.9 years +/-.25-year per ¿ 90205144, for model 3665.The total stimulation on time was 2.02 years, suggesting the device had normal battery depletion to the end of life.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.The device exhibited normal device characteristics during testing.

• Brand Name: PROCLAIM¿ 5 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: 12476267
• MDR Text Key: 271532806
• Report Number: 1627487-2021-17019
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067023247
• UDI-Public: 05415067023247
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2021
• Device Model Number: 3665
• Device Catalogue Number: 3665
• Device Lot Number: 6888763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2019
• 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