MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY PLUS; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	PM1260
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Misconnection (1399)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the patient presented for an right ventricular (rv) lead replacement procedure.During the procedure, it was noted that the casing for the set screw on the pacemaker fell out on the end of the wrench.The pacemaker was explanted and replaced.The patient was asymptomatic to the event.
Additional Manufacturer Narrative
The reported complaint of setscrew problem where setscrew fell off the end of the wrench was not confirmed.No analysis could be performed since the setscrew and wrench were not returned.The torn-out hole in the septum and the setscrew out of the connector block usually indicates the setscrew was stuck to the wrench tip and pulled out of the device tearing a hole through the septum.The problem cannot be confirmed without the analysis of the setscrew and wrench.Electrical test performed indicated normal device characteristics.

• Brand Name: ASSURITY PLUS
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10988837
• Report Number: 2017865-2020-19484
• Device Sequence Number: 19008630
• Product Code: NVZ
• UDI-Device Identifier: 05414734507080
• UDI-Public: 05414734507080
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: PM1260
• Device Catalogue Number: PM1260
• Device Lot Number: 4666374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1