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

Model Number 37601

Device Problems Break (1069); High impedance (1291); Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: product id: 3387s-40, lot# va0wan6, implanted: (b)(6) 2015, product type: lead.Product id: neu_un known_lead, product type: lead.Product id: neu_ins_stimulator, product type: implantable neurostimulator.Product id: neu_unknown_ext, product type: extension.Product id: neu_unknown_ext, product type: extension.Product id: neu_unknown_ext, product type: extension.Product id: neu_unknown_ext, product type: extension.(b)(4).

Event Description

A manufacturing representative reported that during a stage two implant, high impedances were measured on all electrodes of the left brain lead.Impedances of the right light lead were normal.All connections were taken apart, cleaned, and reconnected, but the impedances remained high.The left brain extension was removed and replaced.Impedances were still measured to be high with the new extension.After further examination, a small fracture was noted in the left brain lead near the distal end of the lead and fluid was found inside the insulation.The health care provider tried to suction the fluid out and they covered the fracture with a lead and extension boot.Impedances had gotten better, but they remained high.The issue was not resolved at the time of this report.

• 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: 5000680
• MDR Text Key: 22870733
• Report Number: 3004209178-2015-15946
• 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: consumer
• Reporter Occupation: Other
• Report Date: 07/21/2015

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: 11/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Date Device Manufactured: 06/06/2015
• 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: 00062 YR