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

Model Number 37612

Device Problems Electromagnetic Interference (1194); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Tingling (2171); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that the patient had increased stimulation and ¿side effects¿ after going through a theft detector at a drug store.The following day, it was reported that the patient didn¿t have any problem with therapy until (b)(6) 2013, when the patient went through the theft detector.The patient started to feel shocks in his left arm and had blurred vision the day after.Additionally, the battery was checked with the patient programmer which showed a call-your-doctor icon.After recharging the battery to 100%, the shocks ceased.The following morning, the battery had completely run down.It was recharged again and reset by the healthcare provider (hcp) but the shocks continued.Since then, ¿satisfactory results in the treatment was no longer obtained¿.On (b)(6) 2014, after several attempts, it was possible to set the device to obtain the therapeutic results prior to the theft detector incident.Five days after that however, a call-your-doctor icon was displayed again.The patient also started to feel shocks in his left arm and the battery started to run down quickly.The device was reprogrammed twice after that but that did not ultimately remedy the situation.Stimulation was subsequently turned off.The reporter believed that ¿the device was not supporting amplitude pulses greater than 3v since there was discharge and the need to turn the device off and reduce the amplitude¿.Four days later, it was reported that the patient was charging more than expected.The message that accompanied the call-your-doctor icon could not be recalled.It was further reported that the patient also started feeling tingling in his arm after going through the theft detector.It was unknown if it was a power-on-reset (por) that was displayed along with the call-your-doctor icon.The device reportedly discharged within a day and the patient believed there was a ¿failure¿ with it.Diagnostic testing performed on (b)(6) 2014 showed the typical recharge duration was 0.5 hours and the typical recharge interval was 0 days and the implantable neurostimulator (ins) status was ok.Similar testing done approximately a week later indicated that the typical recharge duration was 0.4 hours and the typical recharge interval was 0.2 days.It was also noted that stimulation was off.Cycling had been off in both cases and the patient had been programmed to 0+,1+,2-,3+ and 8+,9-,10-,11+ on the left and right globus pallidus (gpi) respectively.No information on coupling was provided for both tests.There were no out-of-range impedances found.The charge percentage at the end of recharge sessions varied, but were not always 100%.Approximately two weeks later, it was reported that a ¿malfunction¿ was observed but the cause of the issue was not determined.Telemetry was performed and information pertaining to that diagnostic testing was pending.Surgery was going to be performed, details related to this of which were unknown at the time.The patient was not receiving effective therapy.If additional information becomes available, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Correction: additional review indicated that the "side effects" felt by the patient included a "weird feeling" in their right hand.

• 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: 3702814
• MDR Text Key: 4336952
• Report Number: 3004209178-2014-05131
• 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: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2014

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: 10/28/2012
• 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: 04/21/2014
• Initial Date FDA Received: 03/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2014
• Date Device Manufactured: 12/12/2011
• 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
• Patient Outcome(s): Required Intervention