MAUDE Adverse Event Report: IPG MFG SWITZERLAND KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7428

Device Problems High impedance (1291); Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 11/01/2014

Event Type  Injury  

Event Description

Additional information reported ¿it was possible to stimulate with normal stim-parameters¿ with the patient¿s replacement ins and that the patient received ¿effective stimulation" following the replacement.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) found the battery was at normal end of life and telemetry and output were okay.The charge density warning was confirmed on the ins during analysis.According to the manual a charge density warning will appear if the charge density is above 30 microcoulombs/cm2/phase, which is based on the amplitude and pulse width parameter settings.The charge density warning will appear if the programmed amplitude or the upper limit amplitude along with the pulse width creates a condition above 30 microcoulombs/cm2/phase.Even if the programmed amplitude is low and within the acceptable charge density condition, the warning will still appear if the upper limit is programmed above the acceptable charge density condition.As received for analysis, this ins had the patient control upper limit set to a custom setting of 4.5 volts and a pulse width of 210 ¿s which was high enough to cause the charge density warning to appear even though the programmed amplitude was low.This is normal function for a kinetra ins when using a custom amplitude limit above the acceptable charge density condition, because leaving it in this condition would allow the patient with a patient programmer to set the device to an amplitude above an acceptable charge density condition.

Event Description

It was reported that interrogation of the patient¿s implantable neurostimulator (ins) with a physician programmer ¿showed a charge density warning although the stimulation parameters were far beyond the warning limit.¿ it was stated there were ¿stimulation/therapy issues¿ with ¿less than 50% therapy relief¿ at an unknown location.Ongoing troubleshooting was being performed due to the event at the time of initial report.The patient was alive with no injury at the time of report.It was noted the patient¿s right electrode was positioned in their subthalamic nucleus (stn).Impedance testing found that unipolar electrodes 6 and 7 (on the patient¿s left half) had impedances ¿>4000¿ ohms when tested at 3 volts.Interrogation records indicated the patient¿s right half therapeutic impedance was ¿>4000¿ ohms and the left half returned a ¿???¿ impedance value.It was noted the patient¿s left half was ¿not included in the therapy¿ and was ¿set to 0 volts¿ while the patient¿s right half was set to 1 volt.The patient was reportedly ¿ok¿ 18 days after initial report, but their ¿therapy was not 100% effective.¿ the patient was noted to be scheduled to receive a ¿new ins¿ and undergo an additional impedance test and troubleshooting during an appointment scheduled for 2015-(b)(6).Additional information has been requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 74955136, serial# (b)(4), product type: extension.Product id 74955136, serial# (b)(4), product type: extension.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Event Description

Additional information noted the patient had forgotten and conseuqent missed their (b)(6) 2015 scheduled operation.The patient's operation was rescheduled for (b)(6) 2015 as a result.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: KINETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz MN 1131 ; CH 1131
• 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: 4362417
• MDR Text Key: 5508725
• Report Number: 3007566237-2014-03780
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2010
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2008
• 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): Required Intervention