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

Model Number 7428

Device Problems Low Battery (2584); Device Or Device Fragments Location Unknown (2590); Device Displays Incorrect Message (2591); Malposition of Device (2616)

Patient Problems Edema (1820); Dysphasia (2195); Anxiety (2328)

Event Type  Injury  

Event Description

It was reported the patient had two new leads implanted on (b)(6) 2012 because the target of the patient¿s initial two leads ¿was not accurate.¿ because the patient had ¿brain edema¿ at the time however, the initial two leads ¿were not explanted¿ at the time of implant of the two new leads.While the patient had ¿spoken normally¿ following the initial implant of their device system in (b)(6) 2011, the patient ¿couldn¿t speak¿ after the 2012 implant procedure.The patient¿s doctor reportedly ¿said the symptom was caused by brain edema.¿ the patient was ¿anxious¿ and she ¿spoke unclearly¿ at the time of report, however ¿she had no trembling and rigidity problem¿ at that time.It was noted the patient¿s implantable neurostimulator ¿battery was low¿ at the time of report and remained implanted.It was ¿unknown¿ whether any troubleshooting had been performed or what the patient¿s outcome was following the report.Additional information has been requested.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant products: product id 3389-40, serial # (b)(4), implanted: (b)(6) 2011, product type lead; product id 3389-40, serial # (b)(4), implanted: (b)(6) 2011, product type lead; product id 3387-40, serial # (b)(4), implanted: (b)(6) 2012, product type lead; product id 3387-40, serial # unknown, implanted: (b)(6) 2012, product type lead.(b)(4).

Event Description

Additional information reported the cause of the brain edema was "unknown" at the time of follow-up.It was noted the edema was reportedly "not related with product quality" and that it "had some relevance with therapy, but was not directly related.".

• 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: 4174577
• MDR Text Key: 5157737
• Report Number: 3004209178-2014-19750
• 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,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2012
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2014
• Date Device Manufactured: 05/25/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 00060 YR