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

Model Number 37603

Device Problem Material Twisted/Bent (2981)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Swelling (2091); Complaint, Ill-Defined (2331); Fracture, Arm (2351); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient was experiencing paresthesia and difficulty walking.The symptoms had occurred following implant.The patient had had problems with her arms since the device was implanted in (b)(6) 2012.Both arms had problems, arms were swollen at night time and some nights it was more than others.The patient kept twisting and turning at night because of her arms.After discussing with her healthcare professional the patient was told she was fine.The healthcare professional was seen a long time ago and had not been seen since.The patient had had a problem with their device since surgery and had gone through a 2nd surgery on one side, they had to open up the patient¿s head and do a wiring thing.The patient¿s wires were crooked and the patient had had surgery but they were still the same, the patient had not seen any change.The patient was unsure what was wrong with it because they were having problems with their head but now was having trouble with their neck.Every time the patient saw their healthcare professional they got numb on one side which had never happened before, they had had it before but it had gone away.The patient had had it in both legs prior to surgery.After her legs were fine and her arms, but she could not sleep at night.The patient had a funny feeling in her arms.The healthcare professional told the patient that it had nothing to do with surgery.It was noted that it might be an iron deficiency, but the patient wondered why their legs were not affected since they believed an iron deficiency would not impact just their arms.The patient¿s walking was very bad, she fell on her face when she walked and one time she fell and broke her hand but was told by her healthcare professional that this was not from parkinson¿s.The patient had an appointment scheduled for (b)(6) 2014.The patient had had a computerized tomography (ct) scan and found out there was a problem with the wiring in the brain that they had never told her about.The ct had been taken at the second surgery in (b)(6) 2012.The patient also had an appointment scheduled for (b)(6).No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.Reference manufacturer¿s report number: 3004209178-2015-00143.

Manufacturer Narrative

Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387-40, lot # va00fze, implanted: (b)(6) 2012, product type lead; product id 3387s-40, lot # va005vq, implanted: (b)(6) 2012, product type lead; product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387-40, lot # va00fze, implanted: (b)(6) 2012, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3387s-40, lot # va005vq, implanted: (b)(6) 2012, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension.(b)(4).

• 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: 4384377
• MDR Text Key: 5292490
• Report Number: 3004209178-2015-00144
• 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
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2013
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2014
• Date Device Manufactured: 02/28/2012
• 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