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

Model Number 37601

Device Problem Low Battery (2584)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Respiratory Distress (2045); Dysphasia (2195); Complaint, Ill-Defined (2331); Choking (2464); Shaking/Tremors (2515); Cognitive Changes (2551)

Event Type  Injury  

Event Description

It was reported that a patient was hospitalized for 6 months because her lungs/diaphragm stopped working.One was frozen and the other wasn¿t moving at all.After the patient had the deep brain stimulator (dbs) put in, she started having trouble swallowing, her voice changed, and she was choking all the time.While the patient was in the intensive care unit (icu) her dbs batteries went out.A couple of weeks after the battery went out, her throat started getting better- everyone said ¿you sound wonderful¿.The patient wondered ¿if the dbs affected her throat, could it also have affected her diaphragm¿.The patient was breathing out of the top 1-2 inches of her lungs.After about 3 minutes of standing, the patient would be gasping for air.She is on oxygen ¿24/7¿.The patient had organizing pneumonia and within 2 weeks it was ¿so acute¿.A biopsy was attempted, but it was unknown what the patient had, how she got it, or how to fix it and they haven¿t been able to help her at all.The patient¿s tremors were ¿so bad now¿.When the patient¿s dbs devices were put in, they were affecting her thoughts and she was having trouble saying the right words.When the patient would want to say (b)(6) it would come out (b)(6).When her thoughts would come out, they weren¿t organized.Since the batteries went dead, she can think and say the right words.No interventions or outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.A follow-up report will be submitted when more information becomes available.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v526048, implanted: (b)(6) 2010, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2011, 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: 4096816
• MDR Text Key: 4702467
• Report Number: 3004209178-2014-17214
• 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: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2012
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2014
• Date Device Manufactured: 07/29/2010
• 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): Hospitalization; Required Intervention