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

Model Number 37603

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

Patient Problems Fall (1848); Bone Fracture(s) (1870); Low Blood Pressure/ Hypotension (1914); Neurological Deficit/Dysfunction (1982); Neuropathy (1983); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient¿s hands had started to clasp together during the night since (b)(6) 2013.After that, three months after implant, the patient began falling a lot.The patient fell once or twice a day and in (b)(6) 2014 he broke his leg.The patient had not fallen since that time.The patient had lost a lot of coordination and stumbled when he walked.The patient would hold on to something when he walked to keep himself more stable.This issue had been happening for ¿a while,¿ but the patient could not provide an exact date, and he thought his coordination could be getting worse.The healthcare provider (hcp) thought the cause of the event was gait ataxia or possible orthostatic hypotension with polyneuropathy.The therapy was still working for the patient¿s tremors.The patient had an appointment scheduled with his implant surgeon for (b)(6) 2014.Medical intervention and the patient outcome were not reported, so additional information was requested.If additional information is received, a supplemental report will be sent.Refer to manufacturing report #3004209178-2014-15622 as the patient had two ins¿s and it was not specified which was the issue.

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3387s-40, lot# va0arp9, implanted: (b)(6) 2013, product type: lead.Product id: 3387s-40, lot# va0bbqp, implanted: (b)(6) 2013, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.(b)(4).

Event Description

Additional information received from a consumer reported the patient had been having problems with falling and they fractured their leg in (b)(6) 2014.The patient's health care provider (hcp) was recommending a motorized wheel chair to help prevent falls.In (b)(6) 2015, the patient broke the bones around their eye socket after a fall.The patient's indication for use is parkinson's dual and movement disorders.

• 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: 4024800
• MDR Text Key: 15359422
• Report Number: 3004209178-2014-15623
• 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,Health Professional,consumer,health profess
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• Date Device Manufactured: 05/08/2013
• 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): Other