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

Model Number 7428

Device Problems Degraded (1153); Disconnection (1171); Unintended Collision (1429)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that two months prior to the date of this report, the patient had learned that the leads had become disconnected.It was unknown when or how this had happened.The patient had gone to a new healthcare professional that had checked the device settings and noticed the disconnection.A week after the disconnect was noticed the patient had fallen and cracked his head.The patient was in the hospital where an x-ray was done which found that all the wires were disconnected.The wires were removed and were corroded.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.Reference manufacturer¿s report number: 3004209178-2015-09190.

Manufacturer Narrative

Concomitant products: product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead; product id 3387s-40, lot # v187428, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead; product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was later reported that patient had surgery to take out all the wires which was two weeks prior to the date of this report.The patient's wife thought the wires were not connected properly in 2013 which had caused leakage over the past 2 years prior to the date of this report and therefore corroding the wires.

• 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: 4774671
• MDR Text Key: 20810113
• Report Number: 3004209178-2015-09192
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

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: 01/28/2010
• 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: 06/23/2015
• Initial Date FDA Received: 05/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• Date Device Manufactured: 07/30/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 00074 YR