MAUDE Adverse Event Report: MEDTRONIC, INC. PATIENT CABLE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 5833SL

Device Problems Electrical /Electronic Property Problem (1198); Material Integrity Problem (2978)

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

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when the cable was clipped to the lead and the electrical potential was viewed through the analyzer system, the electrocardiogram (ecg) showed negative injury current.When switched to another cable, the potential become positive.It was recommended that the cable 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 analyzer cable had incorrect continuity.If information is provided in the future, a supplemental report will be issued.

Event Description

The cable was returned for analysis.

• Brand Name: PATIENT CABLE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• 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: 8865692
• MDR Text Key: 153718415
• Report Number: 2182208-2019-01449
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K923407
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: 5833SL
• Device Catalogue Number: 5833SL
• Device Lot Number: 682940001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2018
• 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 Age: 75 YR