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

Model Number 3664

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 10/11/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2024-00650, 1627487-2024-00651, 1627487-2024-00653.Patient also experienced extreme pain and tenderness at the ipg site.It was also reported that patient experienced ineffective therapy and uncomfortable shocking sensation in the back and legs, mostly in the right leg.Targeted pain pattern is bilateral pain both feet.Lead diagnostics showed that all eight contacts on both drg leads had high impedances.Reprogramming was attempted to no avail.Surgical intervention was undertaken on (b)(6) 2024 wherein the ipg and one drg lead were explanted and replaced.One drg lead was unable to be completely explanted due to patient anatomy, so the lead was cut, partially removed and the remainder was left implanted (related manufacturer reference number 1627487-2024-00653).Therapy was restored.

Manufacturer Narrative

Section b3: date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR
• Type of Device: DRG 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18654908
• MDR Text Key: 334724540
• Report Number: 1627487-2024-00652
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2023
• Device Model Number: 3664
• Device Lot Number: 8120628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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: Female
• Patient Weight: 82 KG