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

Model Number 37601

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant: product id 64002, lot# n342445, implanted: 2014-(b)(6), product type adapter.Product id 782a51, serial# (b)(4), implanted: 2011-(b)(6), product type extension.Product id 7482a51, serial# (b)(4), implanted: 2011-(b)(6), product type extension.Product id 3387s-40, lot# v621406, implanted: 2011-(b)(6), product type lead.(b)(4).

Event Description

The patient experienced considerable improvements with the treatment of the device.The end of service (eos) code displayed while usual telemetry with the clinician programmer was done.The same showed a message saying that the battery of the implantable neurostimulator (ins) was run out and that it has to be changed.Premature battery depletion of the ins occurred.The ins had switched off and was tried to switch it on, but it was not possible.The patient had started shivering again.The ins lasted eight months from the implant date to the end of life (eol).Impedance measuring of the poles to prove the state of the electrodes and its connections, showed normal/correct values.It was further reported that a battery longevity estimate was performed using the following settings taken from the clinician programmer: l amplitude: 4.2v pulsewidth: 180's rate: 170hz therapy impedance: 782ohms r amplitude: 4.2v pulsewidth: 180rate: 170hz therapy i mpedance: 811ohms the approximate longevity from the beginning of life to elective replacement indicator (eri) was 8.21 months.The approximate longevity from the beginning of life to eos was 11.21 months.On the clinician programmer report the battery voltage was 2.94v which indicated that there was a significant voltage bounce back after the battery reached eos and turned off.The outcome remains unknown at this time.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

(b)(4).

Event Description

It was later reported that based on the clinician programmer report and battery calculation there was no indication of a problem in the patient's system.It was then reported that the patient needs a new battery.The mdt file indicated the battery reached eos on (b)(6) 2015 after less than 3 months being implanted.The voltage had sharp drops at irregular intervals.

Manufacturer Narrative

(b)(4).

Event Description

The company representative (rep) reported over a month later that one telemetry report showed normal impedances and in the other telemetry report impedances of 100 ohms showed with 1<(>&<)>2, which is exactly the active stimulation contacts.

• 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: 4946595
• MDR Text Key: 24647012
• Report Number: 3004209178-2015-14191
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2015
• Date Device Manufactured: 12/17/2013
• 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: 00068 YR
• Patient Weight: 68