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

Model Number P1501DR

Device Problems Battery Impedance Issue (2884); Battery Problem (2885); Reset Problem (3019)

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

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.

Event Description

It was reported that the implantable pulse generator (ipg) experienced an electrical reset, which removed a software update that provided additional battery measurements.Subsequently, the device did not trigger elective replacement indicator (eri).In addition, the battery impedance was noted to have started to increase recently, although the battery voltage was stable.Reprogramming was performed, and the device remains in use.No patient complications have been reported as a result of this event.

• Brand Name: ENRHYTHM DR
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7090288
• MDR Text Key: 94070680
• Report Number: 3004209178-2017-25013
• Device Sequence Number: 1
• Product Code: NVZ
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/06/2017

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: 10/14/2012
• Device Model Number: P1501DR
• Device Catalogue Number: P1501DR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 12/07/2017
• Date Device Manufactured: 04/25/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1440-2010
• Patient Sequence Number: 1
• Treatment: (B)(4) LEAD, (B)(4) LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR