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 Problems Fall (1848); Bone Fracture(s) (1870); Laceration(s) (1946)

Event Type  Injury  

Event Description

It was reported the patient had been falling.They fell and broke their collar bone and had lacerations on his head.The patient had fallen 13 times since april.It was stated they had one fall in rehab after implant and then started to have more falls after rehab.Impedances were noted as fine.They had turned the deep brain stimulator (dbs) off to see if the patient continued to fall.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.Please see manufacturer report #3004209178-2014-22314 for information on the patient's concomitant system.

Event Description

Additional information received reported the patient did not have a 50 percent or greater symptom reduction.The patient was admitted to the hospital for aggressive deep brain stimulation adjustments, rehabilitation, and ¿bp management.¿ the patient¿s wife relates since deep brain stimulation there was an increase to the patient¿s loss of balance that was first noticed on (b)(6) 2013 at an office visit.The patient had syncope that was a new onset.A ct scan and impedances measurements had been done.The patient had not recovered and the symptoms/issues were ongoing.

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3387s-40, lot# va0ery5, implanted: (b)(6) 2014, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the nurse had inquired if the deep brain stimulator (dbs) could cause orthostatic hypotension.The health care professional was going to turn the dbs off and see whether the orthostatic hypotension would stop.

• 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: 4287020
• MDR Text Key: 5082970
• Report Number: 3004209178-2014-22315
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2014
• Date Device Manufactured: 03/07/2014
• 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): Hospitalization; Other
• Patient Age: 00074 YR