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

Model Number 3660

Device Problem Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2018

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2021-15587.It was reported that the ipg could not be set into mri mode.System diagnostics recorded invalid impedances.As a result, surgical intervention was undertaken wherein the entire system was explanted and replaced to address the issue.

Manufacturer Narrative

A microscopic inspection of the associated penta lead model 3228 found electrode #2 wire had been damaged.Electrical testing of the lead measured less than 4 ohm when performing a resistance test between the lead terminal end electrodes and the corresponding stimulation end electrodes except for electrode #2 measuring an open circuit.It was concluded the damage to the lead wire occurred during the explant procedure as the impedance issue observed in the field was a low impedance (electrode pair 2 measured 150 ohms and electrode pair 16 measured 137 ohms).

• 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: 12177534
• MDR Text Key: 261826231
• Report Number: 1627487-2021-15588
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 5958561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS PADDLE LEAD; SCS PADDLE LEAD
• Patient Outcome(s): Other
• Patient Weight: 76