MAUDE Adverse Event Report: MEDTRONIC, INC. ANALYZER PATIENT CABLE; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number 5436

Device Problem Connection Problem (2900)

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

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during an implant procedure, there was no signal from the leads.It was discovered that the connector of the patient cables were broken.It was recommended that the cables be returned for analysis, but its current status is unknown.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: manufacturer's analysis confirmed the customer comment that the patient cable had no signal.Due to damaged pins in the connector, the cable failed continuity testing through a standard connection.If information is provided in the future, a supplemental report will be issued.

Event Description

The cables were returned for analysis.

• Brand Name: ANALYZER PATIENT CABLE
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8744698
• MDR Text Key: 149523626
• Report Number: 2182208-2019-01169
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5436
• Device Catalogue Number: 5436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 2090 PROGRAMMER, 229047 ANALYZER