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

Model Number 37612

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Muscle Spasm(s) (1966); Muscular Rigidity (1968); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Twitching (2172); Cramp(s) (2193); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Type  malfunction  

Event Description

It was reported that there was a loss of therapeutic effect.Every morning when the patient would wake up he would have spasms in his shoulders and lower legs that would have to be medicated, stimulation adjustment did not seem to help due to the patient either not getting a response or it being too much.If it was too much he would twitch in his shoulder and calf.The patient was seen by his healthcare professional (hcp) in (b)(6) prior to the date of this report.The patient was taking levadopa, advil and lorazapam orally.The patient experienced a lot of pain on the date of this report and the day prior to the date of the report.The patient would get cramping and stiffness to the point that he would be unable to walk and stiffness was painful.It was noted that the patient¿s previous device had worked fine and the patient had other group settings but the current implant was not programmed with other groups.The patient was using the same level of stimulation but it did not help him where it had in the past.The patient had noticed that stimulation level was very low and indicated that it had changed by itself.There was concern about overdischarge.The patient was scheduled to see his hcp on thursday following the date of this report.Patient¿s status was unknown.No outcome or interventions were provided regarding this event.Further follow-up is being conducted to obtain this information and if additional information is received a supplemental report will be submitted.

Manufacturer Narrative

Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 37651, serial# (b)(4), product type: recharger; product id 3387s-40, lot# v487953, implanted: (b)(6) 2010, product type: lead; product id 3387s-40, lot# v487953, implanted: (b)(6) 2010, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2010, 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: 4152858
• MDR Text Key: 4910463
• Report Number: 3004209178-2014-18544
• 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: 09/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2014
• Initial Date FDA Received: 10/08/2014
• Date Device Manufactured: 02/20/2013
• 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 Age: 00059 YR