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

Model Number 37601

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Device Overstimulation of Tissue (1991); Dyskinesia (2363)

Event Type  Injury  

Event Description

Additional information noted that to the physician and patient¿s knowledge, no events had occurred following the reprogramming session that would have affected the system.It was reported ¿the patient was doing well and he was receiving an effective therapy¿ at the time of report.It was stated the patient was ¿probably¿ going to undergo the replacement procedure during the week of follow-up.

Event Description

It was reported the patient had ¿experienced dyskinesias¿ the week prior to report.It was stated the patient¿s physician ¿suspected overstimulation and so changed the parameters¿ from 3 volts at 180 hz and 210 microsec to 2 volts at 130 hz and 60 microsec.It was further stated the patient¿s ¿symptoms improved after reprogramming.¿ it was noted that a x-ray test of the system and impedance testing ¿showed no issues.¿ it was then reported the patient came back to their physician during the week of report because an elective replacement indicator (eri) message had shown up on their patient programmer with the implantable neurostimulator (ins) at 2.8 volts.It was noted the physician programmer was reported to have showed an out of range (oor) message at that time.It was reported the patient was ¿unable to adjust stimulation¿ at the time of report.It was stated that it had been planned but not yet undertaken to replace the patient¿s ins as a result of the event.It was noted the patient was alive with no injury at the time of report.Additional information has been requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluation: analysis of the implantable neurostimulator (ins) found "the ins was received with the eri bit set.The battery had recovered some (2.825 volts when tested on the test console) after the output had been turned off and the ins did not have a load on it.A longevity estimate was done based on the parameter history taken from the ins when it was received for analysis.The parameters were from the oldest record of (b)(4) 2014.The impedances were taken from the measurements shown on the returned printout of (b)(4) 2014.The longevity estimate was 2 years to eri and 2.25 years to eos.According to the trace report taken from the ins, the battery depleted to eri in 2.1 years." the ins was found to have reached ¿normal end of life¿ with okay telemetry and output.

Event Description

Additional information reported that replacement would be done at the end of the week of follow-up.

Event Description

Additional information stated the 쐁tient was doing well�ollowing the replacement surgery.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz MN 55421 120; CH 55421 1200
• 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: 3897093
• MDR Text Key: 4535145
• Report Number: 3007566237-2014-01793
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2012
• 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