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

Model Number 7426

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported the patient had turned the implantable neurostimulator (ins) off due to systemic shocking.The patient was having the ins replaced and during pre-operation impedances were measured to be slightly high, under 3000 ohms on electrodes 2, 3, and 4.Prior to this report all impedances were normal and no fractures were shown on x-ray.After replacing the ins, all impedances were normal.The patient status at the time of this report was alive with no injury.Follow up with the manufacturing representative indicated that there was no change in status and the device was still off.The patient had been referred to the healthcare professional that originally implanted and managed the ins.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.

Manufacturer Narrative

Concomitant products: product id 3387040, lot # v009174, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id neu_unknown_prog, serial # unknown, product type programmer, physician.(b)(4).

• Brand Name: SOLETRA
• 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: 4301001
• MDR Text Key: 5054407
• Report Number: 3004209178-2014-22672
• 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: Physician
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2012
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Date Device Manufactured: 09/28/2010
• 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