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

Model Number 37602

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Tinnitus (2103); Twitching (2172); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37612, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3387s-40, lot# v556377, implanted: (b)(6) 2010, product type: lead.Product id: 64001, lot# n476532, implanted: (b)(6) 2014, product type: adapter.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: 3387s-40, lot# v270501, implanted: (b)(6) 2010, product type: lead.Product id: 37754, serial# (b)(4), product type: recharger.(b)(4).

Event Description

The patient reported that she had an appointment on (b)(6) 2015 with her healthcare provider (hcp) for reprogramming and a botox injection.They are pretty sure that one of the needles went into a lead wire because the patient felt it get poked and got a shock.They checked the impedances and everything looked fine, but they had some trouble getting her to a point where she was not twitchy with the settings she was on, so they put her back to the settings that she came in with and by the time she left she was feeling better.The following day the patient noticed some "shaking on the inside" and she normally did not have these kinds of "tremors." she was having weird symptoms as well, like ringing in the back of her head and ears.The patient also mentioned normally charging on sunday and wednesday and was usually on 50 to 75% after three days.However, she checked her battery on saturday ((b)(6) 2015) and the battery was already at 50%, which was not normal battery depletion for her.She was concerned the battery was depleting faster than usual.The patient spoke to a different hcp, who said based on her settings she should be charging 30 minutes a day, even though in the patient's past experience she had not had to do this.The patient's indications for use were dystonia and movement disorders.No intervention or patient outcome was reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from a healthcare provider (hcp) reported that on (b)(6) 2015, the deep brain stimulator (dbs) bilateral batteries were interrogated.There was no concern for impedance issues.The left generator, which was the rechargeable implantable neurostimulator (ins), was increased from 7.0 to 7.5v.The right generator, which was non-rechargeable, was increased from 5.3v to 5.8v.The patient reported a "shocking" sensation in only the area of the injection.After the "shock" sensation, the stimulators were re-interrogated and all parameters found to be intact as they were before the injection began.The patient returned from lunch due to whole body shaking.Each lead was decreased by 0.4 volts, then reset to settings at the beginning of the visit.This was effective for the right battery.The left battery required to be decreased to 6.7v before baseline returned.The left battery then returned to 7.0v.The patient was given the ability to program voltage +/- 1.0v to desired effect.The botox was given initially with the goal of reducing neck tightness frequently related to severe migraines.The mother notified a provider that the patient was experiencing weakness in the legs, and did not report additional related to the botox of the previous week.The patient was advised that high voltage settings would require longer, more frequent charging.

• 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: 5025513
• MDR Text Key: 26486005
• Report Number: 3004209178-2015-16603
• 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: consumer,health professional
• Reporter Occupation: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Date Device Manufactured: 10/02/2013
• 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: 00022 YR