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

Model Number 5104

Device Problem Connection Problem (2900)

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

It was reported that the analyzer cable was returned to service as an associate product and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

Manufacturer Narrative

Product analysis: at analysis it was determined that the socket of the analyzer cable was disturbed.If information is provided in the future, a supplemental report will be issued.

• 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: 13946873
• MDR Text Key: 288167263
• Report Number: 2182208-2022-00951
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/30/2022

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: 5104
• Device Catalogue Number: 5104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/30/2022
• 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