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

Model Number ADDRS1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/15/2010

Event Type  Death  

Event Description

An implantable pulse generator (ipg) was returned from an unknown source with no information.Information identified in the manufacture¿s database indicated the patient died approximately 4 months post implant of the ipg, approximately 4 years ago.

Manufacturer Narrative

The device(s) associated with this adverse outcome was/were returned from an unknown source with no information.The patient died greater than two years from today.No contacts/events regarding the system have ever been received/reported.Consequently, contact information to complete follow-up is not reasonably known.Therefore, attempts for additional information cannot be made.The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product event summary: the device was returned, analyzed and no anomalies were found.No issues were identified that required full a nalysis.

• 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: 4358178
• MDR Text Key: 5175900
• Report Number: 3004209178-2014-24451
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/14/2010
• Device Model Number: ADDRS1
• Device Catalogue Number: ADDRS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided; 01/12/2015
• Supplement Dates FDA Received: 01/21/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2009
• 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
• Treatment: 1688TC ST JUDE LEAD, 1688TC ST JUDE LEAD
• Patient Outcome(s): Death
• Patient Age: 00087 YR