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

Model Number SEDRL1

Device Problems Output above Specifications (1432); Pocket Stimulation (1463)

Patient Problems Muscle Stimulation (1412); Undesired Nerve Stimulation (1980)

Event Date 08/28/2019

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 implantable pulse generator (ipg) capture measurements of the right ventricular (rv) lead threshold mismatched with manual measurements of rv lead thresholds.As a consequence of the high thresholds, the muscle, nerve and pocket stimulation occurred.The device was reprogrammed but the matching values were not obtained.The ipg and rv lead remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated pacing capture management showed high output in the right ventricular chamber.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENSIA IPG
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9097151
• MDR Text Key: 159315898
• Report Number: 3008973940-2019-02593
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 10/01/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2017
• 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: 09/02/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/01/2019
• Date Device Manufactured: 10/22/2015
• 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
• Treatment: 4068 LEAD, 4081 LEAD
• Patient Outcome(s): Required Intervention