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

Model Number 2002L

Device Problem Difficult to Interrogate (1331)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the asymptomatic patient presented to the clinic after being lost to follow up.The nurse had difficulty interrogating the pulse generator.No intervention or additional information was available at this time.

Event Description

New information reported stated that the device was explanted and replaced on (b)(6) 2015.No additional information was reported.

Manufacturer Narrative

Final analysis confirmed the device had reached normal end of life.

• Brand Name: SOLUS
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5035548
• MDR Text Key: 24355168
• Report Number: 2017865-2015-27953
• Device Sequence Number: 1
• Product Code: LWP
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/1998
• Device Model Number: 2002L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/1996
• 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): Required Intervention
• Patient Age: 52 YR