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

Model Number 37603

Device Problem High impedance (1291)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported that the patient was scheduled for lead, extension, and implantable neurostimulator (ins) exploration on (b)(6) 2014 due to high impedances with intermittent loss of therapy.At the time of the report there were no impedance details.The exploratory surgery was to examine the connections to try and fix the high impedances or locate the issue.Two days later it was reported that the exploration case was cancelled and did not have a re-schedule date yet.The reporter did not program the patient.Additional information received reported that all combinations with the case had impedances that measured to be greater than 40,000 ohms after the implantable neurostimulator (ins) was replaced.The following impedances were measured: 0-1 = 4423, 0-2 = 6982, 1-3 = 6475, and 2-3 = 5200 ohms.Prior to the ins being replaced, impedances were measured to be the following: c-0 = 7412, c-1 = 6752, and c-3 = 8348 ohms.The manufacturing representative knew this was a lead issue because impedances were measured to be between 8000-9000 ohms when the lead was tested.The ins was in the pocket and the patient had already been closed.The ins was changed for another reason other than the impedance issue.The plan was to reseat the extension into the ins and double check the connections.Disconnecting and reinserting the extension into the ins did not resolve the high impedances.Refer to manufacturer report #3004209178-2014-13547.

Manufacturer Narrative

Concomitant products: product id 3387s-40, lot # va00p3q, implanted: (b)(6) 2012, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37603, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type implantable neurostimulator; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3389s-40, lot # v853915, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3387s-40, lot # va00p3q, implanted: (b)(6) 2012, product type lead.(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: 4751935
• MDR Text Key: 5787751
• Report Number: 3004209178-2015-08537
• 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
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Date Device Manufactured: 03/04/2015
• 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