MAUDE Adverse Event Report: MEDTRONIC, INC. PACING SYSTEM ANALYZER; PROGRAMMER, PACEMAKER

Model Number 229003

Device Problems Use of Device Problem (1670); Output Problem (3005)

Patient Problem Convulsion, Clonic (2222)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient started to convulse immediately after the leads were connected to the analyzer during an implantable pulse generator (ipg) exchange procedure.The programmer electrocardiogram (ecg) showed high frequent noise.The leads were disconnected from the analyzer and the convulsions stopped.The analyzer and programmer are expected to be returned for analysis.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: the complaint was unconfirmed.The analyzer passed incoming inspection and testing, with no anomalies observed.If information is provided in the future, a supplemental report will be issued.

Event Description

On 2019-09-26: the analyzer was returned for service.

• Brand Name: PACING SYSTEM ANALYZER
• Type of Device: PROGRAMMER, PACEMAKER
• 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: 9078494
• MDR Text Key: 158873020
• Report Number: 2182208-2019-01677
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 229003
• Device Catalogue Number: 229003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2002
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR