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

Model Number 37603

Device Problem Low impedance (2285)

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

Event Type  Injury  

Event Description

It was reported that the patient¿s whole system was being removed because of a short on the lead itself.The managing neurologist was unable to program around it.It was noted the patient had one lead implanted in their left vim.It was noted that electrode 0 and 3 showed 96 ohms.Refer to manufacturing report #3004209178-2014-05027 for the information pertaining to the patient¿s first ins that prematurely depleted due to the short.

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: 2011-(b)(6), explanted: 2014-(b)(6), product type: implantable neurostimulator.Product id: 3387s-40, lot# v727699, implanted: 2011-(b)(6), product type: lead.Product id: 37085-60, serial# (b)(4), implanted: 2011-(b)(6), product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.(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: 4777649
• MDR Text Key: 5800888
• Report Number: 3004209178-2015-09256
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• Date Device Manufactured: 12/13/2013
• 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