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

Model Number 37601

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211)

Patient Problems Paralysis (1997); Loss of Range of Motion (2032); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that stimulation was turning off on its own and the patient did not know what was causing it.The patient was not feeling confident with the patient programmer and inquired if he was reading the programmer right.The patient had had programming done in (b)(6) 2015 and programming was not helping with symptoms.The patient had called their healthcare professional about this.On (b)(6) 2015, the implantable neurostimulator (ins) was turned off and he was seeing stimulation at 2.5v on one side and 3.5v on the other side and it said off on the top.The ins was turned back on.The ins had turned off on saturday prior to the date of this report and it was a normal day.It was off on monday and the left arm was paralyzed, he could not lift his arm or move his elbow over his shoulder.The patient takes 9 doses of sinemet and had stated he had ¿worst days and bad days and the bad days are not good.¿ the patient was in a wheel chair.Further follow-up is being conducted.If additional information is received a supplemental report will be submitted.

Manufacturer Narrative

Concomitant products: product id 3389s-40, lot # v939343, implanted: (b)(6) 2012, product type lead; product id 3389s-40, lot # v939343, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, 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: 4865984
• MDR Text Key: 5811230
• Report Number: 3004209178-2015-12134
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• Date Device Manufactured: 03/02/2012
• 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): Other
• Patient Age: 00059 YR