MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SENSIA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number SEDR01

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Muscle Stimulation (1412); Chest Pain (1776); Palpitations (2467)

Event Date 08/23/2019

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 presented with stimulation at the site of implantable pulse generator (ipg) implant, palpitations and chest pain.Polarity switch, oversensing and intermittent far field r-wave (ffrw) oversensing and high thresholds were noted on the right atrial (ra) lead on electrograms (egm).A lead warning was alerted for low and high impedance.It was noted the ipg appeared to be migrating.The ipg and ra lead remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

It was also reported that the patient was admitted.It was further reported that the lead was reprogrammed and remains in use.

• Brand Name: SENSIA IPG
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9128153
• MDR Text Key: 160331931
• Report Number: 3004209178-2019-18540
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00613994222138
• UDI-Public: 00613994222138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• 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: 11/28/2014
• Device Model Number: SEDR01
• Device Catalogue Number: SEDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/01/2019
• Date Device Manufactured: 05/30/2013
• 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: 407645 LEAD, 407652 LEAD
• Patient Outcome(s): Hospitalization
• Patient Age: 90 YR