MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Twitching (2172); Discomfort (2330); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3708640, serial# (b)(4), product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and manufacturing representative regarding a patient who was implanted with a neurostimulator (ins) for dystonia and movement disorders.It was reported that the patient woke up this morning with stabbing and aching pain on the ins and they don't know if that is normal.Caller reports the patient go hit/popped last night at church with a whistle on the back of her head where the wires are located but caller doesn't think that has anything to do with it.Caller was crying last night because it hurt.Caller states patient programmer shows therapy is on/ok.Additional information was received from the manufacturing representative indicating that the patient's ins pocket site is causing the shocking sensation.Impedance has been checked out fine at the office visit and no device issue was seen.No falls or trauma reported.Caller also reports patients mother indicated ins battery is depleting much faster.Caller reports patient holds the recharger when she charges.They had no coupling bars except for 1 session had 18 minutes with 5 coupling bars.Patient's mother reports shocking, sharp stabbing and aching sensation is all around the device system and they got hit by a whistle behind the ear.Patient's mother indicated with stimulation on/off and palpating on the device, reports patient reports pressing does hurt.The patient has been reporting right hand tremor and when device is turned off the patient's eye twitches.The patient's quality of life has gotten worse since her old devices.No further complications were reported or anticipated with this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative indicating that the patient has been seen at the clinic and they will continue to monitor the progress of the patient.The patient is stable and receiving therapy.If the problem persists they will intervene surgically.No other updates at this time.

Manufacturer Narrative

The main component of the system and other applicable components are: product id 3708640, serial# (b)(4), product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient via a manufacturer's representative (rep).It was reported that the patient experienced unusual sensations in the pocket site and parents complained therapy was not as good as previous with two primary ins's.The surgeon interrogated surgical sites and couldn't find any issues.Impedance testing was done.The ins was removed and replaced.It was unknown if the issue was resolved at the time of the report.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.: conclusion code updated from 92 to 11.Continuation of: explant/implant dates updated: product id 3708640 lot# serial# (b)(4) implanted: explanted: 2018 (b)(6) product type extension product id 3708660 lot# serial# (b)(4) implanted: 2013 (b)(6) explanted: 2018 (b)(6) product type extension.If information is provided in the future, a supplemental report will be issued.

Event Description

No additional information was received.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) (serial # (b)(4)) revealed the batteries functionality was okay with insig nificant anomalies.Analysis of the extension (serial # (b)(4)) revealed that the extension body was stretched.Analysis of the extension (serial # (b)(4)) revealed that the extension had a breached depression in the outer insulation of the body.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7294356
• MDR Text Key: 100934668
• Report Number: 3004209178-2018-03908
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2015
• 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
• Patient Age: 11 YR