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

Model Number 7428

Device Problems Break (1069); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Seizures, Grand-Mal (2168); Anxiety (2328)

Event Date 08/03/2004

Event Type  malfunction  

Event Description

It was reported the device was turned on at 5 volts for contacts 1, 2, 5, and 6 and the patient had an immediate ¿panic attack.¿ the device was turned off and restarted fifteen minutes later at the same contacts but at 1 volt.Ten minutes later the patient had a generalized tonic-clonic seizure.The event was noted as ongoing.The event involved in-patient hospitalization.Intervention also included reprogramming.It was noted there was a torqued connection at number 7 revealed by x-rays that were taken to evaluate questionable impedance values.Review of post-operative films showed it occurred at implant.It was also noted that the stimulator was turned off by the patient.The patient had a temporary discontinuation of stimulation.The event was noted as resolved without sequelae.

Manufacturer Narrative

Product id 3387-40, lot# j0428349v, serial# implanted: 2004 (b)(6); product type lead product id 33 87-40, lot# j0428349v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0428349v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0428349v, implanted: 2004 (b)(6); product type lead.(b)(4).

Event Description

Additional information received reported that the patient had elective hospitalization for eeg monitoring.

• 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: 3710533
• MDR Text Key: 4336571
• Report Number: 3004209178-2014-05295
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2005
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2014
• Date Device Manufactured: 06/16/2004
• 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; Other
• Patient Age: 00024 YR