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

Model Number 37601

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

Patient Problems Fall (1848); Unspecified Infection (1930); Dysphasia (2195); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient had thought the deep brain stimulator would have a positive effect on the quality of life but it had been the opposite.The patient had first had surgery to help the right side tremor and it had gone well so they decided to have the left side done which was in (b)(6) 2013.That was when the problems had started and they had not stopped.Side effects impacted the patient¿s balance and speech which eventually lead to the patient falling.Following a series of tests they found out the patient had a brain infection.The patient spent time in the hospital getting treated for the infection and was still trying to get ¿c.Diff¿ under control.It was noted that it had been one thing after another and the patient had believed it all started with the frayed wire.The patient was still doing out patient rehab to help with balance and speech but the patient had been told speech would not get much better.The patient was concerned not much would get better.It had been a disaster.There were serious side effects that would impact the patient¿s family and him the rest of his life.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

Event Description

Additional information received reported the patient started having trouble with balance and speech after a revision surgery.Due to balance issues, the patient fell and ended up in the hospital.While the patient was in the hospital, an mri was done and they found a brain infection.The lead had to be explanted and the patient spent several weeks in intense rehab learning how to walk and talk again.

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3387s-40, lot# va0bh3r, implanted: (b)(6) 2014, product type: lead, product id: 3387s-40, lot# va0b0xv, implanted: (b)(6) 2013, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.(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: 4460634
• MDR Text Key: 5402784
• Report Number: 3004209178-2015-01350
• 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,Followup
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• Date Device Manufactured: 06/17/2013
• 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; Required Intervention
• Patient Age: 00064 YR