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

Model Number 3661

Device Problem Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.

Event Description

It was reported that the patient underwent an unrelated surgical procedure.Patient did set the ipg into surgery mode as recommended.Thereafter, the ipg failed to establish communication with external device.Recovery efforts were unsuccessful and the ipg was deemed inoperable.Patient is not receiving therapy and may require surgical intervention to address the issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Actions have been taken to prevent reoccurrence.

Event Description

Additional information received identified that patient underwent surgical intervention wherein the ipg explanted and replaced.Effective therapy was restored post operatively.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Actions have been taken to prevent reoccurrence.

• Brand Name: PROCLAIM¿ 5 IMPLANTABLE PULSE GENERATOR, HEADER M
• 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: 12591019
• MDR Text Key: 275196931
• Report Number: 1627487-2021-17445
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020208
• UDI-Public: 05415067020208
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2020
• Device Model Number: 3661
• Device Catalogue Number: 3661
• Device Lot Number: 7117814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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
• Patient Sex: Male
• Patient Weight: 95 KG