MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ACCENT DR RF PACEMAKER; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PM2210

Device Problem Device Sensing Problem (2917)

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

Event Type  Injury  

Event Description

It was reported, that the patient's pulse generator exhibited decreased, r waves sensing measurements.The pulse generator was explanted.Patient status was unknown.

Manufacturer Narrative

The reported event of r-wave amp variation was not confirmed.The device was received with normal output and telemetry communication.Analysis performed including saline cross talk test and output verification was normal.Longevity assessment found the device was operating at elective-replacement voltage (eri), consistent with normal projected longevity.

• Brand Name: ACCENT DR RF PACEMAKER
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18729903
• MDR Text Key: 335700814
• Report Number: 2017865-2024-32969
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: H758PM221001
• UDI-Public: 05414734503617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: PM2210
• Device Lot Number: 4591965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 02/24/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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
• Treatment: OPTISENSE; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female