MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 7428

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2012

Event Type  Injury  

Event Description

On (b)(6) 2012 caller thinks ins being replaced to go to different technology per caller, she doesn't think ins is depleted yet.2017-04-11 additional information was received from a friend or family member of the patient.It was reported that the patient¿s ins would periodically turn off when they would go into a store, so it was ultimately replaced.The patient was implanted for dystonia.

Manufacturer Narrative

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

• Brand Name: KINETRA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6490321
• MDR Text Key: 72728964
• Report Number: 3004209178-2017-08241
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

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: Health Professional
• Device Expiration Date: 02/28/2012
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: 04/11/2017
• Supplement Dates FDA Received: 10/03/2017
• Date Device Manufactured: 09/08/2010
• 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): Required Intervention
• Patient Age: 30 YR