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

Model Number ADDRL1

Device Problem Battery Problem (2885)

Patient Problems Fainting (1847); Discomfort (2330)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076-45 lead implanted: (b)(6) 2002.(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported that "the battery basically died." the patient also noted feeling forceful beats up into the neck, almost passing out once, and experiencing extreme discomfort due to the device being at recommended replacement time (rrt).The device was explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADAPTA 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: 7765592
• MDR Text Key: 116526067
• Report Number: 3004209178-2018-17755
• 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,Followup
• Report Date: 10/03/2018

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: 09/14/2009
• Device Model Number: ADDRL1
• Device Catalogue Number: ADDRL1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/02/2018
• Date Device Manufactured: 03/27/2008
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR