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

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Muscle Weakness (1967); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported there was a loss of therapeutic effect.The patient was falling.He used to fall before having the implantable neurostimulator (ins) but now he was starting to fall again.They fell 2-3 times two days prior to report and went to the er at midnight.The patient fell again several times the day prior to report and went to the er again at 10pm.While the patient was in the er they had a ct scan on the head.The ct scan that was done in the emergency room was negative.He also fell several times while on vacation for 2 months in (b)(6) 2015.The patient was trying to walk and he had been freezing in his legs.They had told him to move his legs and he couldn¿t.It was noted that this was something the patient had previously to the ins.The falls had been getting worse and because of the falls, he had torn his left shoulder out of the pocket and he has to get his left shoulder fixed.His legs were deteriorating and he doesn¿t have strength in his legs.Additional information received 3 days later reported there was not a 50% or greater symptom reduction.The cause of the event was not determined and it was unknown if it was device related.It was unknown if reprogramming was needed.The patient wondered if a ¿wire came loose with falls.¿ the patient was going to be hospitalized on (b)(6) 2015 and they would check for wire fracture.They would have an upcoming admission to the hospital for medication adjustment.The patient had not yet recovered and they were in physical therapy.

Manufacturer Narrative

Concomitant products: product id 3389s-40, lot # v333260, implanted: (b)(6) 2009, product type lead; product id 3389s-40, lot # v276341, implanted: (b)(6) 2009, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37642, serial # (b)(4), product type programmer, patient.(b)(4).

Event Description

Additional information received reported that the patient was admitted at the hospital and the therapy was reviewed.There were no lead issues noted, no lead fractures, or loose wires due to the falls.The patient's medications were adjusted and they were continuing to monitor medications at the time of report.The therapy was working as designed and there were no malfunctions noted.

• Brand Name: ACTIVA
• 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: 4898863
• MDR Text Key: 6829671
• Report Number: 3004209178-2015-12963
• 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
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 07/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/23/2015
• Date Device Manufactured: 05/07/2013
• 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): Hospitalization
• Patient Age: 00068 YR