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 06/19/2010

Event Type  Death  

Event Description

An implantable pulse generator (ipg) system was returned to the manufacturer from a funeral home with no additional information.Further review of the manufacturer¿s database indicated the patient died approximately eight months after device replacement.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.The devices associated with this adverse outcome were returned from a funeral home with no information.Consequently, contact information to complete follow-up is not reasonably known.Therefore, attempts for additional information cannot be made.(b)(4).

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis was performed and no anomalies were found.

• 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: 4336565
• MDR Text Key: 5217313
• Report Number: 3004209178-2014-24110
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2015

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: 02/14/2011
• Device Model Number: ADDRS1
• Device Catalogue Number: ADDRS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 12/17/2014
• Supplement Dates Manufacturer Received: Not provided; 01/14/2015
• Supplement Dates FDA Received: 01/29/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2009
• 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-2120-2011
• Patient Sequence Number: 1
• Treatment: 5076-58 LEAD, 4592-53 LEAD
• Patient Outcome(s): Death
• Patient Age: 00091 YR