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

Model Number 7426

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Shaking/Tremors (2515); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported that the patient was complaining of the device spontaneously turning off.The device was turned back on at the healthcare providers (hcp) office.Testing was completed including battery voltage and impedances and both were normal and within range.Reprogramming was also completed.Before the patient left the office, the device had turned off again.Then it was then turned on, as well before the patient left.When the patient was home, the device powered of again, and then the patient turned in back on with his hand held patient programmer.The patient status at the time of report was alive with no injury.It was later reported that the patient was having trouble with holding silverware to have breakfast the morning of the report due to his hand shaking.The patient noted that (b)(6) his hands were shaking more and then got relief in the right hand by adjustment.It was then reported that a battery was purchased for the patient programmer, the ins was off, and then the patient turned stimulation back on.The patient felt a shock in his arm, which was noted to be normal when the implant was turned back on.Then, the patient was getting control of his hand again and was receiving effective therapy.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v354660, implanted: (b)(6) 2009, product type: lead.Product id: 7438, serial# (b)(4), product type: programmer, patient.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.(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: 4078222
• MDR Text Key: 4741606
• Report Number: 3004209178-2014-16734
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2011
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2014
• Date Device Manufactured: 10/22/2009
• 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