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

Model Number 37601

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Seizures (2063); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported the patient had been admitted to the hospital for "spells of involuntary posturing, convulsion," which started to occur 8 days ago.The issue had also happened 2-3 weeks prior to the report date.The patient felt a shock-like sensation and the physician was concerned about potential fracture of the deep brain stimulation (dbs) lead wires.X-rays were going to be performed to assess the integrity of the dbs system.An impedance test was performed with impedances ranging from 813 ohms to 3096 ohms on the left side and impedances ranging from 885 ohms to 1757 ohms on the right side.There were plans to do imaging with mri two days from now to look for potential tissue damage.It was noted the patient had access to increasing amplitude and voltage on the left side and right side of the implantable neurostimulator (ins).The patient could go as high as 6 volts on the left side and 5 volts on the right.The patient was currently programmed 0-, 3+ and 4-, 7+, but was to be reprogrammed 0-, 2+ on the left side to avoid contact #3 since its impedance value was 3096 ohms.The symptoms were reported to have occurred on the right side, and an attempt was made to see if palpation and if head positional changes would cause reoccurrence of symptoms.No outcome was provided with this event.Further follow up is being conducted to obtain this information.A follow up report will be sent if additional information is received.

Manufacturer Narrative

Concomitant products: product id 3389s-40, lot # v061739, implanted: (b)(6) 2007, product type lead; product id 7436, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v061739, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, 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: 4298508
• MDR Text Key: 5195556
• Report Number: 3004209178-2014-22620
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2014
• Date Device Manufactured: 09/26/2011
• 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; Other