MAUDE Adverse Event Report: MEDTRONIC, INC. ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number ADDR06

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Twiddlers Syndrome (2114)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article:unique abdominal twiddler syndrome journal of arrhythmia.2019; 35(1):142-144.10.1002/joa3.12133.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding an implantable pulse generator (ipg).The authors described that six weeks post implant the patient presented with an abdominal protrusion and intermittent pain at the pocket site.Regardless of the patient¿s position the ipg ¿took a spontaneous stand up position in the abdominal pocket.¿ prior to presenting to the hospital the patient repeatedly manipulated the device from the perpendicular to the flat position within the pocket.Additionally, abdominal distention due to chronic constipation and intestinal gas led the ipg to spontaneously re-stand in a perpendicular position.A pocket revision was performed and following there was resolution of the device rotation and pain.The device remains in use and no patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.

• Brand Name: ADAPTA
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10182093
• MDR Text Key: 196068589
• Report Number: 2182208-2020-01146
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2020

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 Model Number: ADDR06
• Device Catalogue Number: ADDR06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 06/22/2020
• 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: 82 YR