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

Model Number ADDR01

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 04/29/2009

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

The patient reported that the device is smaller than their previous device and it "floats around" in the pocket, often flipping and rotating.This wakes the patient up at night when the device is sitting "perpendicular" and pushes on the muscles and ligaments.The patient further reported that it hurts when they move their arm and it doesn't fit in the pocket.The patient has discussed this with the physician but the patient does not want any more surgeries.The device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: ADAPTA DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5283744
• MDR Text Key: 33484599
• Report Number: 3004209178-2015-24714
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2010
• Device Model Number: ADDR01
• Device Catalogue Number: ADDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• Date Device Manufactured: 03/03/2009
• 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: 00076 YR