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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that a patient¿s stimulation was ¿shutting down¿ and he was not feeling any benefit.It was noted that therapy stopped two days prior to the report.The reporter stated that the patient programmer was displaying ¿call your doctor¿ and out of regulation (oor).It was reported that the patient saw the message the previous evening and had contacted the doctor, who wanted to see the patient but not until (b)(6) 2014.It was noted that the patient tried the programmer and it was working.The patient saw ¿yes¿ and ¿ok¿ after pressing the check key and saw the lightning bolt.It was reported that the patient couldn¿t feel anything and usually felt stimulation.It was noted that the patient asked if one of the leads was broken.Two days later, it was reported that the patient wasn¿t able to adjust stimulation and there was an oor condition.It was noted that a manufacturer representative was asked to see the patient to evaluate the impedance reading.The left side showed 924 ohms and 7.27 milliamps, and the right side showed 3030 ohms and 2.243 milliamps.It was reported that the doctor interrogated the device and did not see any oor or other message on the clinician programmer.It was noted that the oor message was seen during the weekend when a cat walked or jumped across the patient¿s chest.It was reported that electrode 7 showed higher than the normal 1000 ohms and higher, but the patient was not using that electrode.On the right side, the patient was programmed with case positive, 6 negative at 6.8 volts, 120 pulse width and 120 hz and rechecking therapy impedance showed 3014 ohms and 2.255 milliamps.On the left side, the patient was programed with 1 positive, 2 and 3 negative at 6.8 volts, 90 pulse width, and 120 hz and rechecking therapy impedance showed 924 ohms and 7.273 milliamps.It was reported that the day of the report when the device was interrogated, the oor message was not seen.It was noted that the implantable neurostimulator (ins) was last charged on (b)(6) 2014, the battery showed 75 percent charge the day of the report, and the ins battery was lasting longer than before.It was reported that before the patient needed to charge every two days.The reporter stated that the patient was part of a voice study and had turned the stimulation off for an hour last week.It was noted that the patient had been keeping stimulation on, he was wheelchair bound, and he had been unable to walk since saturday.It was reported that the ins battery was at 3.9 volts and impedance readings were the same with palpation or neck turning.Five days later, it was reported that there was an open circuit on the right lead and on (b)(6) 2014 there was a return of symptoms, the device was checked and it was turned off and at 20 percent charge.It was turned back on and charged fully.It was noted that there were no problems charging and it was charged to 100 percent.It was reported that a healthcare provider (hcp) verified that the device was on and charged but it didn¿t appear that the patient was getting any therapeutic response.The medical workup was negative and all impedances with electrode 7 appeared to be greater than 10,000 ohms.It was noted that the last therapy impedance done in (b)(6) was 791.The reporter stated that there was a possible open and medically they could not program with electrode 4.It was reported that they couldn¿t program around it and there was a possible revision.It was noted that the amplitude had always been around 6.8 volts.A week later, it was reported that the cause of the event was unknown and was presumably attributed to the ins.It was noted that therapy impedance on the right hemisphere increased from 900 to 3000.It was reported that the ins issue was unknown and it was not delivering therapy.It was noted that an x-ray and ct scan on (b)(6) 2014-02-25 were normal and a time for ins replacement would be determined.Symptoms associated with the event included acute worsening of parkinson¿s disease symptoms and the patient didn¿t require hospitalization.It was reported that the event was ongoing and the patient symptoms were still not controlled until surgery.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v218104, implanted: (b)(6) 2009, product type: lead.Product id: 3387s-40, lot# v218104, implanted: (b)(6) 2009, product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3387s-40, lot# v218104, implanted: (b)(6) 2009, product type: lead.Product id: 3387s-40, lot# v218104, implanted: (b)(6) 2009, product type: lead.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v218104, implanted: (b)(6) 2009, product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3387s-40, lot# v218104, implanted: (b)(6) 2009, product type: lead.

Event Description

Additional information received reported the manufacturing representative had not been made aware of a replacement surgery scheduled or performed.The patient was sent back to their programmer for an adjustment to resolve the issue.It was noted that the battery had not appeared to be in need of replacement.The patient outcome was that the patient appeared to be receiving stimulation and getting therapy.

• 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: 3671177
• MDR Text Key: 4347160
• Report Number: 3004209178-2014-04197
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• 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: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2014
• Date Device Manufactured: 05/21/2010
• 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: 00058 YR