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

Model Number 7428

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported the patient was having shocks and there was a question of some malfunction of the implantable neurostimulator (ins) when the patient met with their healthcare professional (hcp) on (b)(6) 2010.The patient¿s right side was programmed to 5-, 6-, 7+ at 4v, 90 usec, and 185 hz and their left side was programmed to 1-, 3+ at 3.8v, 90 usec, and 185 hz.There was a question of an intermittent circuit problem.The hcp felt the ins should be replaced.After the ins was replaced, impedances were all measured to be normal and the ins was programmed using the patient¿s old settings.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v101646, implanted: (b)(6) 2008, product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 3387s-40, lot# v108523, implanted: (b)(6) 2008,product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.(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: 4760204
• MDR Text Key: 5949915
• Report Number: 3004209178-2015-08771
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2008
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Date Device Manufactured: 06/01/2007
• 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