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

Model Number 37601

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Itching Sensation (1943); Pain (1994); Pocket Erosion (2013); Depression (2361); Shaking/Tremors (2515); Fluid Discharge (2686)

Event Type  Injury  

Event Description

It was originally reported on (b)(6) 2014 that the patient¿s device was trying to erode through his skin again.The patient¿s device worked great but its size was a huge problem.The patient is retired and not as active as he wants for fear of having more problems.It was noted the patient tried to be very careful of the area surrounding the battery but he slept on his side and had been awakened by an itchy sensation and some light pain.The patient did not want to go back to drug therapy for parkinson¿s but on the other hand he could not go in surgery every 8-9 months.Additional information received two days later reported the patient¿s doctor told him that if his device eroded through his skin again he may potentially need to have the device taken out or the lead wires rerouted.Three weeks later it was reported that the cause of the event was pocket erosion.The event was attributed to the implantable neurostimulator (ins) and its poor design of being large and square.The ins and extensions were explanted; the leads were left in place.The patient was placed on intravenous antibiotics the day prior to explant.The associated signs and symptoms were pain, drainage, and severe recurrence of tremor.The patient outcome was marked as a serious ongoing illness as the patient had severe parkinson¿s disease symptoms and was put on very high doses of medications with poor tremor control and side effects.The patient had suffered a loss of independence and was very depressed.

Manufacturer Narrative

Concomitant products: product id 3389s-40, lot # v535392, implanted: (b)(6) 2011, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v535392, implanted: (b)(6) 2011, product type lead.(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: 3666880
• MDR Text Key: 20265167
• Report Number: 3004209178-2014-04060
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2012
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2014
• Date Device Manufactured: 09/15/2010
• 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