MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problems Premature Discharge of Battery (1057); Failure to Deliver Energy (1211); Low impedance (2285); Low Battery (2584)

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

Event Type  Injury  

Event Description

It was reported that there was a there was a possible problem with the implantable neurostimulator (ins).It was noted that the patient was implanted in early may with bilateral devices.One device was able to be interrogated and turn on/off but the other device shows the on/off button on the clinician programmer greyed out.It was unknown why this was.The patient¿s stimulation had turned off on its own sometime between the week prior to the date of this report and the date of this report.Therapy impedance was 80ohms and battery voltage was 2.935.The healthcare professional had originally tried to interrogate with the clinician programmer but still on/off was greyed out.No messages were seen when interrogating.Programming was switched to 1-2+ and nothing changed.The device was re-interrogated and there was an end of service (eos) indicated.Electrode impedance readings were c/0-1366, c/1-1366, c/2-2206, c/3-2376, 0/1-33, 0/2-3031, 0/3-3409, 1/2-3044, 1/3-3409 and 2/3-3862.Historical impedances were not available.It was later reported they were getting ready for surgery and the ins battery voltage was measured at 2.95v.It was unknown if the healthcare professional had programmer about the short circuit electrode.It was later reported that there was low impedance of 32 on electrodes 0 and 1.Action required as a result of the event was reprogramming.Impedance testing was done.The cause of the issue was not determined and it was unknown if the issue had resolved.There was premature battery depletion and the action required as a result was a replacement.The issue was not resolved.There were no patient symptoms reported.Additional information was requested but had not been received as of the date of this report.

Manufacturer Narrative

Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator; product id 3389s-40, lot# va0fgjj, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3389s-40, lot# va0fgjj, implanted: (b)(6) 2014, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.(b)(4).(b)(6).

Event Description

Additional information received reported the short circuit was found during pre-operative interrogation and it was also present during an intra-operative test.The intra-operative test printout was not available.

Manufacturer Narrative

Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id 3389s-40, lot# va0fgjj, implanted: (b)(6) 2014, product type: lead.Product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id 3389s-40, lot# va0fgjj, implanted: (b)(6) 2014, product type: lead.Product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 3929816
• MDR Text Key: 4588427
• Report Number: 3004209178-2014-12914
• 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: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2014
• Date Device Manufactured: 04/02/2014
• 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
• Patient Age: 00064 YR