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

Model Number 37601

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Low impedance (2285)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

It was reported that the patient was not getting good therapy like his previous device.An mri was done and it showed good bilateral location.However, it showed something and no physician could tell what.They were unsure if it was edema around the lead location or ¿tracking¿ from the previous lead location.The patient was tolerating the system well neurologically.Impedances were measured and the electrode combination of 2 and 3 was found to be 107 ohms.The electrode combinations of 8 and 9, 8 and 10, and 9 and 10 were all over 4,000 ohms.No interventions or patient outcome were reported, so additional information was requested.If additional information is received a supplemental report will be sent.Refer to manufacturing report #3004209178-2014-01346 as the patient¿s previous device was removed due to an infection.

Manufacturer Narrative

Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# va0l5dp, implanted: (b)(6) 2014, 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: 4466441
• MDR Text Key: 16560322
• Report Number: 3004209178-2015-01437
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• 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: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• Date Device Manufactured: 04/04/2014
• 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 Age: 00050 YR