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

Model Number 7428

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Muscular Rigidity (1968); Skin Erosion (2075)

Event Type  Injury  

Event Description

It was reported that the patient experienced infection due to skin breakdown at the lead site in (b)(6) 2013, three years after implant.There were no other signs or symptoms of infection.The right lead was cut and explanted.The hcp ¿got the lead stopped working¿ and ¿wrapped it in the plastic tube.¿ the infection resolved.On (b)(6), the patient¿s limbs became rigid and the patient suspected the left lead had stopped working.It was found that the implantable neurostimulator (ins) was off.The ins was turned on and reprogramming was performed.The patient was ¿good¿ after reprogramming.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial# unknown, product type: lead.(b)(4).

• 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: 4182435
• MDR Text Key: 5019590
• Report Number: 3004209178-2014-19943
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2011
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• Date Device Manufactured: 12/07/2009
• 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: 00066 YR