MAUDE Adverse Event Report: MEDTRONIC, INC.; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number 5487

Device Problem Connection Problem (2900)

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

Event Date 04/09/2014

Event Type  Injury  

Event Description

It was reported that there was a disconnection of the clamping system between the cable and the pacemaker.The clamping system was inefficient and could disconnect during transport with risk of asystole.The cable was changed and returned to the manufacturer.No patient complications were reported as a result of this event.

Manufacturer Narrative

This event occurred outside the u.S where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Product event summary: analysis confirmed the reported event, the cable lock on the device plug was broken so it would not hold into the connector.Resistance and continuity testing revealed no anomalies.No intermittent connection found when cable was bent or manipulated.(b)(4).

• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• 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: 3991640
• MDR Text Key: 4891769
• Report Number: 2182208-2014-02119
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K960446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/02/2014

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 Model Number: 5487
• Device Catalogue Number: 5487
• Device Lot Number: 439160001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2014
• 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
• Patient Outcome(s): Required Intervention