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

Model Number 3662

Device Problem Battery Problem (2885)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, attempts were made to obtain weight but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the end of service (eos) message displayed for the ipg on external devices.It is unknown if the ipg depleted prematurely.In turn, the patient underwent surgical intervention wherein the ipg was explanted and replaced to address the issue.

Manufacturer Narrative

An error message displaying ¿replace generator.The generator has reached the end of its service¿ when patient was trying to connect to the ipg was reported to abbott.The ipg was explanted and replaced.Therapy was restored.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12546631
• MDR Text Key: 273771529
• Report Number: 1627487-2021-17310
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020222
• UDI-Public: 05415067020222
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2019
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 6049569
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR