MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS SENSIA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number SEDRL1

Device Problems Invalid Sensing (2293); Capturing Problem (2891)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use of the implantable pulse generator (ipg) an inquiry was received regarding inconsistent and inaccurate capture management measurements compared to in clinic manual thresholds.Incoming information indicated that the right ventricular (rv) lead impedance was stable, and in the clinic, manual testing of the rv thresholds and sensitivity were stable as well.The caller was informed regarding the potential of the ipg not detecting the evoked sense response appropriately.Troubleshooting of the ipg was scheduled, and the ipg remains in use.No patient complications have been reported as a result of this event.

• Brand Name: SENSIA DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SG 486056
• Manufacturer (Section G): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SG 486056
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7415461
• MDR Text Key: 105242698
• Report Number: 3008973940-2018-00499
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980035
• 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
• Report Date: 04/10/2018

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: Lay User/Patient
• Device Expiration Date: 12/28/2018
• Device Model Number: SEDRL1
• Device Catalogue Number: SEDRL1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 04/10/2018
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR