MAUDE Adverse Event Report: MEDTRONIC, INC. PACEART SYSTEM; ELECTROCARDIOGRAPH

Model Number P127TUV

Device Problem Signal Artifact/Noise (1036)

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

Event Date 03/21/2014

Event Type  Injury  

Event Description

The module was returned and a replacement was sent.

Manufacturer Narrative

Product event summary: analysis could not confirm the reported event; module passed visual, electrical and mechanical inspection with no faults or anomalies observed.

Event Description

It was reported that the caller indicated that users at the client's clinic were getting "static discharge errors" when performing both clinic and trans telephonic monitor (ttm) transmissions with the electrocardiogram (ecg) module.Of note, the caller indicated that there is a stress testing machine in the next room, although not in use.Technical services (ts) provided assistance in resolving the issue by explaining that the static is a result of the environment and provided recommendations regarding users "grounding themselves" before starting checks and ways to reduce static build up in the room.Further follow up did not provide any additional information regarding the ecg error.The module was to be returned and a replacement was sent.No patient complications were reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACEART SYSTEM
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3858488
• MDR Text Key: 4822094
• Report Number: 2182208-2014-01657
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P127TUV
• Device Catalogue Number: P127TUV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention