MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that about 2.5 weeks after implant an infection was found, the left side was infected and had to be redone because of the infection.Everything on the left side was removed 3-4 months prior to the date of this report due to the infection.It was noted that the right side was fine.The patient had just recently had a new rechargeable implantable neurostimulator (ins) implanted in their abdomen.It was noted that this replacement had not been due to normal battery depletion.The left side had to be rewired due to the infection.The left side was rewired and the right battery was taken out and replaced with a rechargeable ins also.The patient stated ¿they rewired the left and took out the right battery and replaced the right with a rechargeable ins and connected the newly installed left side to the existing right side.¿ they had done this because, the battery was only going to be good for a year.The patient had obsessive compulsive disorder and tourette syndrome.The patient¿s mother had stated that the patient programmer was beeping and turning itself on, it was noted that this was a feature to remind the patient the check the ins battery.The patient¿s mother would prefer to have 8 programs instead of only 4, the patient¿s mother used the multiple programmer to adjust therapy for her daughter.The patient was infection free and doing well, thought she was getting accustomed to her new rechargeable.

Manufacturer Narrative

Product id 37603, serial# (b)(4), implanted: 2014 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# v866904, implanted: 2012 (b)(6); product type lead product id 37085-95, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 3387s-40, lot# v866904, implanted: 2012 (b)(6); product type lead product id 37085-95, serial# (b)(4), implanted: 2012 (b)(6); product type extension.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4418307
• MDR Text Key: 20323284
• Report Number: 3004209178-2015-00692
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2014
• Date Device Manufactured: 02/05/2014
• 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: 00016 YR