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

Model Number 37601

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Type  malfunction  

Event Description

It was reported that there was a loss of therapeutic effect.It was noted that the healthcare professional (hcp) was trying to address ¿glitchy issues¿ with the implantable neurostimulator (ins).On (b)(6) 2014 the patient had checked the implant with the patient programmer due to worsening symptoms and had discovered the device was off but it should have been on.Hcp had worked with the patient on (b)(6) 2013 and the device was on at that time which was when the last clinician programmer interrogation had been performed.It was noted that the patient had an acute decompensation before getting into the clinic on the date of this report.It was noted that the patient¿s right side symptoms came back ¿with a vengeance.¿ there was no usage data on the clinician programmer before (b)(6) 2014.Patient was having shaking on the right side on (b)(6) 2014 and when the implant was turned back on the symptoms had resolved.It was noted that ¿things were status quo¿ until two days prior to the date of this report patient¿s right leg had become very dystonic and was still dystonic.The patient was having good beneficial response on (b)(6) 2013 and the end of the session had confirmed implant was on.Impedances looked good except for contact 8, bipolars with contact were 6500-8200 ohms and molopolar was 6800.It was noted that the patient had visited her sister in the hospital on (b)(6) 2014 and that may have had an effect on her system but that was speculative.It was later reported that it looked like the device was off after the last programming on (b)(6) 2013.The patient had checked it on (b)(6) 2014 and turned the ins on.Stimulation was off between (b)(6) 2013 and (b)(6) 2014.Stimulation was turned on between (b)(6) and (b)(6) 2014, which was confirmed with parameter trend and stimulation time diagnostic.It was unknown whether stimulation was on or off in the time leading up to (b)(6) 2013.It was further noted that only the impedances for the other lead, 0-3 were taken not 8-11 lead.Electrode 0-3 all looked good ranging from 1398 to 2964 ohms for both uni-polar and bi-polar.It was noted that when the patient left the programming session on (b)(6) 2013 the device was off.It was noted that the device had not been turned off by an outside source but rather was turned off with the clinician programmer session end.Additional information was requested but had not been received as of the date of this report.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v875210, implanted: (b)(6) 2012, product type: lead.Product id: 3387s-40, lot# v829968, implanted: (b)(6) 2012, product type: lead.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 8840, serial# unknown, product type: programmer, physician.(b)(4).

Event Description

Additional information received reported that the patient's summary report from (b)(6) stated the implantable neurostimulator (ins) was on.There was no additional report downloaded from the clinician programmer and one would have been generated if the ins was interrogated again after that one.The reporter did not have a second reported that indicated that ins was off.Four days later it was reported that the previous report of the ins being off at the end of the session on (b)(6) 2014 was incorrect.The stimulation was on at the end of the clinician programmer session on (b)(6) 2014, but later that day the ins was turned off with a patient programmer.The ins remained off until (b)(6) 2014.The doctor exited the session as she intended, with the stimulation on.Someone else had turned the ins off with a patient programmer.

• 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: 3777527
• MDR Text Key: 18931784
• Report Number: 3004209178-2014-08209
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2014
• Date Device Manufactured: 09/28/2011
• 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