MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3231-40Q

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

Patient Problems Syncope (1610); Congestive Heart Failure (1783); Dyspnea (1816); Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  Injury  

Event Description

It was reported that the patient presented remotely via merlin.Net transmission.Upon interrogation of the device, premature battery depletion was observed.Review of the stored transmissions confirmed the anomaly.The patient would be routinely monitored until elective replacement is reached.

Manufacturer Narrative

(b)(4).

Event Description

New information stated that following the battery performance alert (bpa) advisory, a bpa was received by the clinician on (b)(6) 2017 and the device was explanted.The patient was stable throughout the whole event.

Event Description

New information on 4/24/18 stated that the patient could not breath and passed out on (b)(6) 2018.The patient was admitted into the emergency room and it was discovered that the patient had septic.Antibiotics was given and the patient could continue to be monitored.

Event Description

New information on (b)(6) 2018 stated that the patient was admitted to the hospital for congestive heart failure and had difficulty walking.The patient would continue to be monitored and no further information was available.

Manufacturer Narrative

The reported battery performance alert and premature battery depletion was confirmed by analysis.Bench testing on the device was performed, and no sources of high current were noted.The cause of the premature battery depletion was consistent with li cluster formation.From these analyses, in the absence of high current draw, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.

Manufacturer Narrative

Li clusters are a known depletion mechanism for these advisory products that has been investigated and associated with a field action in (b)(6) 2016.Correction: method code (b)(4) should be removed since no electrical evaluation was performed during the analysis.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6697986
• MDR Text Key: 79521813
• Report Number: 2017865-2017-06187
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/25/2018

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: 08/31/2012
• Device Model Number: CD3231-40Q
• Device Catalogue Number: CD3231-40Q
• Device Lot Number: 3328570
• Other Device ID Number: 05414734504393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 09/01/2017; 01/09/2018; 04/24/2018; 05/14/2018; 05/14/2018
• Supplement Dates FDA Received: 09/20/2017; 02/06/2018; 05/08/2018; 05/16/2018; 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0116-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR