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

Model Number 37603

Device Problem Electromagnetic Interference (1194)

Patient Problems Twitching (2172); Complaint, Ill-Defined (2331)

Event Date 11/06/2014

Event Type  Injury  

Event Description

It was reported the patient¿s mother felt the patient had more pulling in their neck and their arm was twitching since the implantable neurostimulator (ins) was turned off for a dental procedure on (b)(6) 2014.The patient¿s mother stated they did not think it was a huge change.The healthcare professional (hcp) last saw the patient in (b)(6) and the neck pulling was noted to be the same as on the day of this report.The hcp did think the patient¿s arm was better on the day of this report.The ins batteries were at 2.71v and 2.79v.All impedances were measured to be normal.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.Refer to manufacturer report #3004209178-2015-00761.

Manufacturer Narrative

Concomitant products: product id 37603, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 3387s-40, lot # va0czmx, implanted: (b)(6) 2013, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3387s-40, lot # va0czmx, implanted: (b)(6) 2013, product type lead.(b)(4).

Event Description

Additional information received reported an elective replacement indicator (eri) message was displayed.The healthcare professional (hcp) saw the patient in the clinic on (b)(6) 2014 and the patient¿s dystonia had been declining.The patient had not been checking the implantable neurostimulator (ins) everyday, but they had seen the eri message on the day of this report.The hcp was not able to interrogate the left ins with their clinician programmer.The patient¿s parameters had been changed frequently.Prior to (b)(6) 2014, the patient was programmed to c+, 1-, 2- at 5v, a pulse width of 120, and a rate of 160 hz with a therapy impedance of 628 ohms.A longevity calculation with those settings found eri to be 10.52 months and end of service (eos) at 13.52 months.The patient left the appointment on (b)(6) 2014 with the pulse width changed to 180.The longevity calculation was done again and it was 6.81 months to eri and 9.81 months to eos.At the time of this report the right ins was at 2.71v and it was 2.79v on (b)(6) 2014.A replacement surgery was going to be scheduled.

Manufacturer Narrative

(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: 4422783
• MDR Text Key: 5168819
• Report Number: 3004209178-2015-00762
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 01/15/2015
• Date Device Manufactured: 09/19/2013
• 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): Required Intervention
• Patient Age: 00010 YR