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

Model Number 7428

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

Patient Problems Pain (1994); Dysphasia (2195); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37601, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 64002, lot# n494166, implanted: (b)(6) 2015, product type: adapter.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: 3387s-40, lot# v487953, implanted: (b)(6) 2010, product type: lead.Product id: 3387s-40, lot# v511640, implanted: (b)(6) 2010, product type: lead.(b)(4).

Event Description

Information was received from the company representative that reported the deep brain stimulator (dbs) leads were in the right place but when he turned his stimulation on he had more pain and was unable to walk and couldn't speak but his tremors were controlled.They were never told about the dbs side effects.The patient believed it was the dbs that put him in a wheelchair.These issues were from the time of implant.It was a sudden change in therapy/symptoms.The patient was implanted for dystonia.Additional information received 6 days later reported the patient was seen in recovery following a battery replacement and was still feeling the effects of anesthesia.He previously had a primary cell device and now with the new implantable neurostimulator (ins) patient programmer (pp) the patient thought he would be able to better titrate his stimulation per his neurologist.The only option the patient wanted to take in post-operation was to set his stimulation at a lower level or to turn his stimulation off.They were instructed how to do so using the programmer.The patient needed to rest after surgery so the company representative wasn't able to do any troubleshooting.The patient was going to follow-up with their neurologist to further troubleshoot/diagnose issues related to pain, speaking, and walking.Further follow-up was being conducted to determine what troubleshooting/diagnostics were done to address the patient's symptoms.If additional information is received, a follow-up report will be submitted.

Event Description

Additional information received from the health care professional (hcp) reported the patient's complaints were related to the device/dystonia and not to the movement.Impedances were intact and deep brain stimulator (dbs) was functioning.

• Brand Name: KINETRA
• 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: 5148388
• MDR Text Key: 28222574
• Report Number: 3004209178-2015-20568
• 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: Other
• Type of Report: Followup
• Report Date: 09/22/2015

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: 02/14/2012
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Date Device Manufactured: 08/21/2010
• 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
• Patient Age: 00024 YR