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

Model Number 5103

Device Problems No Device Output (1435); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment that the signal using the adaptor cable failed to display through the pacing system analyzer (psa) on programmer.It was noted that there was a pin bent in the plug of the adapter cable.It was confirmed that all visual incoming inspection passed with no anomalies found, correct resistance was found between the pins, all continuity tests were fine and no intermittent or shortened connections found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that when using the adapter cable the signal would not display through the analyzer on a mobile programmer and a legacy programmer.It was noted that new cables were used however no signal was present.The user connected to the device and the signal was present.It was noted that the issue observed was near the male side and when the adaptor was inserted into the analyzer input a slight clockwise rotation would bring back the signal and it then functioned properly.No patient complications have been reported as a result of this event.

• Brand Name: ADAPTOR CABLE
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• 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: 12033022
• MDR Text Key: 257182286
• Report Number: 2182208-2021-02507
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5103
• Device Catalogue Number: 5103
• Device Lot Number: ID2100041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 118