MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS ENRHYTHM DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number P1501DR

Device Problem Low Battery (2584)

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

Event Date 10/28/2013

Event Type  malfunction  

Event Description

The device was returned after being explanted due to normal battery depletion.The device subsequently tested out of specification during manufacturer's analysis.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.The device was returned and analyzed.The device did not meet expected longevity.Analysis results of the device and internal components were as expected for a pacemaker at eri (elective replacement indicator).Without the history of the programmed settings throughout its service life, there is no way to determine why the longevity did not match the predicted model.Concomitant product: 4592-53 non-defib lead, implanted: (b)(6) 2010.(b)(4).

• Brand Name: ENRHYTHM DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS; road 31, km. 24, hm 4;; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3860857
• MDR Text Key: 4659040
• Report Number: 3004209178-2014-10496
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/18/2014

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: 04/14/2011
• Device Model Number: P1501DR
• Device Catalogue Number: P1501DR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2009
• 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: 4592-58 NON-DEFIB LEAD, IMPLANTED: (B)(6) 2010
• Patient Age: 00075 YR