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

Model Number 3660

Device Problem Insufficient Information (3190)

Patient Problems Inadequate Pain Relief (2388); No Information (3190)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

During processing of this incident, attempts were made to obtain complete event and device information.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-48079.It was reported that the patient¿s scs system was explanted and replaced with a new scs system on (b)(6) 2020 for an unknown reason.

Event Description

Additional information received indicates that the ipg was not communicating with external device and was deemed inoperable.As such, surgical intervention took place to address the issue.During the, procedure high impedances were noted on the lead.As such, ipg and lead were explanted and replaced with a new scs system.Reportedly, therapy was confirmed post operatively.

Manufacturer Narrative

Additional information: device information was provided and is included in this submission as well as device return and evaluation status.

Manufacturer Narrative

The reported allegation that stimulation could not be achieved was confirmed based on the statement in the record that stimulation could not be achieved at any time, and during the explantation, the electrode was tested with a test cable and all contacts of the electrode had impedances above 3000 ohms.Ppe lab analysis of the lead found all lead wires to be fractured.This high impedance failure mode of the lead would cause the ipg output stimulation to turn off and the stimulation would not be allowed to be turned back on.Analysis of the ipg showed it was responsive and communicated with lab utilities.It was running the therapy app and functional.It successfully bonded with a lab cp without any connectivity issues.The device was tested to manufacturing specifications using the ate and passed all tests.The ipg functioned as intended.

• Brand Name: PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10879912
• MDR Text Key: 217654590
• Report Number: 1627487-2020-48078
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 6865490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS LEAD, MODEL 3186.
• Patient Outcome(s): Other