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

Model Number 37601

Device Problem High impedance (1291)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that high impedances of 3,000 to 6,000 ohms were measured on the left lead.The extension and implantable neurostimulator (ins) were replaced, but high impedances were still measured.Due to the patient¿s prior ins, they had a pocket adaptor so both extensions were replaced.After removing the pocket adaptor and replacing the extensions, the healthcare professional (hcp) plugged the extensions directly into each port of the ins.High impedances were measured to be greater than 40,000 ohms.The manufacturing representative wanted to know if there was an issue with removing the plug and using that port.The hcp tried disconnecting and reconnecting the system, but that did not resolve the issue.The patient would most likely have the lead replaced.The ins had blood in the top clear part of the device, which the healthcare professional (hcp) had not seen before.The issue was not resolved at the time of this report.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.Refer to manufacturer report #3004209178-2015-14385.

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# v149877, implanted: (b)(6) 2008, product type: lead.Product id: 3389s-40, lot# v161578, implanted: (b)(6) 2008, product type: lead.Product id: 37601, serial# (b)(4), implanted: (b)(6) 2013-, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 64002, lot# n401763, implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: adapter.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 3389s-40, lot# v149877, implanted: (b)(6) 2008, product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2015, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2015, product type: extension.Product id: 7436, serial# (b)(4), product type: programmer, patient.Product id: 3389s-40, lot# v161578, implanted: (b)(6) 2008, 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: 4953986
• MDR Text Key: 14217041
• Report Number: 3004209178-2015-14386
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2015
• Date Device Manufactured: 05/08/2015
• 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
• Patient Age: 00053 YR