MAUDE Adverse Event Report: MEDTRONIC, INC. PROGRAMMING HEAD; PROGRAMMER, PACEMAKER

Model Number	2067L
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Injury (2348)
Date of Event	04/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: it was determined at analysis that the radiofrequency head does not work, no interrogation was possible due to a break in the inner core of the cable.Damage was not visible from the outside.The rf head cable was replaced.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient is pacemaker dependent, during the procedure whilst using the analysers surgical cable, transmission was lost between the analyser and the implanted electrode.There was a sudden loss of stimulation, no peaks were visible on the monitor, connection and the lead position was checked, cardiac massage during asystole was required.After change to another programmer and another measuring cable regular stimulation took place again.The procedure was completed using a different device.It was further reported the programmer was used the following day with no issues reported.Hospitalisation and intervention was required as a result of this event.The programmer will be returned for service to be tested with the cable.Injury reported.

• Brand Name: PROGRAMMING HEAD
• Common Device Name: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10332964
• Report Number: 2182208-2020-01372
• Device Sequence Number: 826000
• Product Code: KRG
• UDI-Device Identifier: 00613994435125
• UDI-Public: 00613994435125
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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
• Operator of Device: Other
• Device Model Number: 2067L
• Device Catalogue Number: 2067L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2090 PROGRAMMER, 2292 ANALYZER, SURGICAL CABLE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention