MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7428

Device Problem Shelf Life Exceeded (1567)

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

Event Date 08/05/2013

Event Type  malfunction  

Event Description

It was reported the parkinson's disease patient¿s implantable neurostimulator (ins) was implanted past the manufacturer¿s use by date (ubd).No additional information was available at the time of initial report.A supplemental report will be filed if additional information is received.

Event Description

Additional information reported the manufacturer shipped the device to the customer on (b)(6) 2012¿ prior to the ubd.

Manufacturer Narrative

(b)(4).(b)(6).

• Brand Name: KINETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4334591
• MDR Text Key: 5139758
• Report Number: 3004209178-2014-24075
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2013
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2015
• Date Device Manufactured: 12/08/2011
• 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 Age: 00075 YR