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

Model Number 37601

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Brain Injury (2219); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that when the patient¿s implantable neurostimulator (ins) was replaced, they could feel it zap them.The patient was semi-conscious when the batteries were replaced.The patient stated that it seemed ¿like the wire would catch it or go through the ins.¿ the patient clarified it was not a real zapping, but it was like when they ins was adjusted and they felt the difference in settings.The patient wondered if they damaged their brain already.The patient needed surgery for skin cancer of their nose and they thought they may have to need cauterization and they were worried about not being able to get the ins back on if it was turned off.If the patient was not able to turn the ins back on they had ¿full blown parkinson.¿ the deep brain stimulation worked will for the patient and they did not want to go without it.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.

Manufacturer Narrative

Product id 64002, lot# n321934, implanted: 2012 (b)(6); product type adapter product id 3387-40, lot# j0454428v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0454516v, implanted: 2004 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 748240, serial# (b)(4), implanted: 2004 (b)(6); product type extension product id 748240, serial# (b)(4), implanted: 2004 (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: 4309848
• MDR Text Key: 5192700
• Report Number: 3004209178-2014-22874
• 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: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2014
• Date Device Manufactured: 08/12/2014
• 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): Other
• Patient Age: 00069 YR