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

Model Number 37602

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that there was a possible problem with the implantable neurostimulator (ins).It was noted that the implantable neurostimulator (ins) depletion was being reported as premature.It was noted the last visit in (b)(6) of 2013, both batteries were >2.90.It was noted that on the date of report the right ins was 2.95 and the left ins was 2.63.It was further noted that the settings of the left ins were ¿strange¿ at 0- ,1-,2+,3+; ¿2.0/90/180.¿ it was noted that impedance was 1097 with a current of 1.848.It was noted that a longevity calculation was run with a result of 5-6 years.It was further noted that this only took into account impedance and not configuration.Additionally, it was noted that when an impedance check was done the healthcare professional (hcp) received a message stating that the amplitude delivered might be lower than intended (or something like that) and the hcp should consider reducing the voltage or lowering number of active contacts.It was noted that it made no sense to the hcp.The hcp attempted re-measuring and planned to take a photo but every subsequent measurement went through fine without the error message.It was noted that the hcp did a full impedance check and no problems were found.It was noted that the manufacturer representative conducted another longevity check at the same settings with the result of 5.46 years to elective replacement indicator (eri) and 5.71 years to end of service (eos).The manufacturer representative would look at past records for higher settings that may have caused the issue or any impedance data reflecting low impedance or shorts in the past.It was noted that it may have been an intermittent short.It was not known if the patient had any symptoms return in the past.Additional information received reported that the manufacturer representative left a message for the hcp to give a call and discuss the patient settings and whether or not there were any other issues.It was noted that the manufacturer representative had not heard back from the hcp.It was noted that per manufacturer's device registration, the device was explanted (b)(6) 2014.

Event Description

Additional information received reported that the devices were replaced the week prior to 2014 (b)(6).The patient was doing well as the manufacturer representative had not heard any complaints from the hcp.The manufacturer representative noted that they had spoken to the hcp on 2013 (b)(6) and they did not mention the patient.The manufacturer representative was awaiting the disposition of the devices.

Event Description

Additional information received reported that the cause of the event was unknown.It was noted that there were no abnormal impedance measurements.It was noted that the battery depletion was premature.It was noted that the battery as replaced as an intervention.It was noted that the patient did not require hospitalization due to the event.It was noted that the patient recovered without sequela.

Manufacturer Narrative

Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3389-40, lot# j0222859v, implanted: (b)(6) 2002,product type: lead.Product id: 3389-40, lot# j0222859v, implanted: (b)(6) 2002, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension.(b)(4).

• Brand Name: ACTIVA
• 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: 3595748
• MDR Text Key: 4167450
• Report Number: 3004209178-2014-01290
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2012
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• Date Device Manufactured: 06/24/2011
• 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