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

Model Number 7428

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Numbness (2415); No Code Available (3191)

Event Type  Injury  

Event Description

Additional information reported the patient¿s implantable neurostimulator (ins) system was replaced on 2014-(b)(6).

Event Description

It was reported that the patient was implanted on (b)(6) 2008 due to dystonia.In (b)(6) 2013, the patient had gone to the hospital for programming.It was noted that the patient was told that the product could remain for only 4-6 months.In (b)(6) 2014, the patient had experienced arm numbness and difficulty opening eyes.Additional information received reported the reason for the patient symptoms was unknown and it was unobtainable whether they were related to a device malfunction.It was unobtainable whether this was expected/normal or premature battery depletion.Patient¿s family was considering replacing the product.It was unobtainable whether patient would have replacement of their system.Additional information received reported that the patient was planning to have a replacement operation.

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: 3649772
• MDR Text Key: 4329527
• Report Number: 3004209178-2014-03673
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2010
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2014
• Date Device Manufactured: 09/04/2008
• 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): Required Intervention