MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE EP-4 CARDIAC STIMULATOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 09-1463-0120

Device Problem Loss of Threshold (1633)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event was requested but not received.

Event Description

During the procedure, the stimulator would not pace through any channel and the procedure was cancelled.The cable was exchanged, the pins were adjusted and the system was restarted with no resolution.The patient was prepped and the procedure was cancelled.The patient was stable with no patient consequences.

Manufacturer Narrative

One ep-workmate¿ scu-signal conditioning unit (amplifier), was received for investigation.Inspection of the input and output connectors confirmed the field reported issue as the connector for the lower bank channels (57-120) shows signs of physical damage to multiple electrical contact pins on the scsi (small computer system interface) connector body.The damage indicated is consistent with connecting a damaged scsi cable into the cim connector.No functional testing was performed as the product was returned in a condition that does not permit additional testing.Based on the information provided to abbott and the investigation performed, the root cause of the reported event was isolated to physical damage to multiple electrical contacts within the small computer system interface connector.The event which resulted in the physical damage was not communicated and remains undetermined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: EP-WORKMATE EP-4 CARDIAC STIMULATOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10081082
• MDR Text Key: 191822764
• Report Number: 2184149-2020-00071
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K092810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 09-1463-0120
• Device Catalogue Number: 09-1463-0120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 06/02/2020; 07/24/2020
• Supplement Dates FDA Received: 06/23/2020; 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Weight: 67