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); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem Electric Shock (2554)

Event Date 10/02/2015

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id 3708660, serial # (b)(4), product type extension; product id neu_unknown_lead, serial # unknown, product type lead.

Event Description

Information received via a healthcare professional from a clinical study reported the patient had a battery replacement on (b)(6) 2016 due to the stimulator "not working right" and shocking the patient.Impedances were checked during the case and nothing alarming was found but the impedances were a little high on the right.It was noted during the implantable neurostimulator (ins) replacement surgery, a "minor rent approximately 5 centimeters" before the ins was noted on the lead.There was a lead fracture, but the cause of the fractured lead remained unknown.The healthcare provider and representative were not aware of the lead fracture until they had gone in to replace the ins.The fractured lead was replaced on (b)(6) 2015.The patient's indication for use was dystonia and movement disorders.

Event Description

Additional information received reported the cause of the shocking and the device not working correctly was due to the lead fracture.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6073929
• MDR Text Key: 59007744
• Report Number: 3004209178-2016-23075
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2016

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: 06/14/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided; 11/02/2016
• Supplement Dates FDA Received: 11/03/2016; 09/27/2017
• Date Device Manufactured: 12/15/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 42 YR