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

Model Number 37612

Device Problems Disconnection (1171); High impedance (1291); Unexpected Therapeutic Results (1631); Device Displays Incorrect Message (2591)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported the new rc generator placed on (b)(6) 2014 had not been as ¿effective¿ as the previous generator.The manufacturing representative stated the patient had seen an oor message of the programmer about a week and a half prior to the call.An impedance test was run on (b)(6) 2015.Results showed the top port (left side) had no issues but the bottom port (right side) contact 4 had high impedance.A second impedance test was run on the day of the call and the values had changed.Results showed the top port (left side) all combinations with contact 0 or 1 had high impedance and the bottom port (right side) had same issue, all combinations with contact 4 were high.It was inquired on how the impedances had changed and the manufacturing representative thought there was a connection issue and that an adaptor was used.The doctor programmed around the issue contact but the patient was not doing well.A revision was scheduled the week of (b)(6).No falls or traumas were reported and patient outcome is unknown.Further follow-up has been requested to obtain this information and if additional information becomes available a follow-up report will be sent.

Event Description

Additional information received reported that the manufacturer representative (rep) saw the patient on the day of the report in the clinic and did an impedance check.Multiple combinations on the left and right side were greater than 10,000 ohms; the combination of 0 and 1 was even greater than 40,000 ohms.The revision was scheduled for (b)(6) 2015.On the day of the revision it was reported that the 0 and 4 electrodes were high.The other values were within normal range, so they wanted to reprogram around the high electrodes.

Event Description

Additional information received reported the patient had shaking symptoms from parkinson¿s disease with the deep brain stimulation system.The shaking had always been present since implant and the therapy did not help.

Manufacturer Narrative

Concomitant medical products: product id 64002, lot# n242111, implanted: (b)(6) 2010, product type: adapter; product id 3389s-40, lot# v207104, implanted: (b)(6) 2009, product type: lead; product id 3389s-40, lot# v207104, implanted: (b)(6) 2009, product type: lead; product id 37651, serial# (b)(4), product type: recharger; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id neu_unknown_prog, serial# unknown, product type: programmer, physician.(b)(4).

Manufacturer Narrative

(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: 4446994
• MDR Text Key: 5388726
• Report Number: 3004209178-2015-01135
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 01/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/13/2015; 05/07/2015
• Date Device Manufactured: 09/06/2014
• 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: 00065 YR