MAUDE Adverse Event Report: ABBOTT ENDURITY¿ CORE DR, JPD; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PM2152

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Type  malfunction  

Event Description

During an initial implant procedure, the lead was not able to be fixated into the header port of the device.A new device as selected and implanted to resolve the event.

Event Description

Additional information was received that the set screw was not able to be tightened into the header port of the device.

Manufacturer Narrative

The reported event of unable to tighten the setscrew to fix the lead in the header was confirmed.Analysis revealed the user of the torque wrench was incorrectly inserting the torque wrench into the setscrew inset stripping the inset.When the setscrew inset is being stripped it cannot be tightened.The user continued with incorrect wrench insertions until the inset was completely stripped.No device anomalies were found.The problem is related to the user's use of the torque wrench.The setscrew anomaly was consistent with having occurred during the procedure.

• Brand Name: ENDURITY¿ CORE DR, JPD
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17886269
• MDR Text Key: 325090149
• Report Number: 2017865-2023-47854
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM2152
• Device Lot Number: P000165228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2023
• 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