MAUDE Adverse Event Report: MEDTRONIC, INC. PACEART OPTIMA; ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT

Model Number POS12D14

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

It was reported that the client mentioned several times that the data issues had not been fixed in the new release of the patient management database (db).The client would like it be fixed in the next release.The client had given a list of data issues to someone at human resources.The client has to manually change or add the data because the data was not coming in correctly.The client noted that the percentage of pacing for a device in managed ventricular pacing (mvp) mode populate erroneously, the single chamber pacing modes populate the upper tracking rate which does not apply to single chamber pacing, and the atrial refractory does not populate.Db remains in use.No patient involvement or 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).

• Brand Name: PACEART OPTIMA
• Type of Device: ANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT
• 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: 4159036
• MDR Text Key: 16782528
• Report Number: 2182208-2014-02590
• Device Sequence Number: 1
• Product Code: KRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: POS12D14
• Device Catalogue Number: POS12D14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1