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

Model Number 37602

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Date 10/14/2016

Event Type  Injury  

Manufacturer Narrative

Product id 37602 lot# serial# (b)(4) implanted: (b)(6) 2016 explanted: product type implantable neurostimulator.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A manufacturer representative (rep) reported that after the patient's battery was changed on (b)(6) they felt like they were doing better ever, almost as if they didn't have parkinson's disease.However, this feeling only lasted 2 weeks and now they feel like the device is no longer helping them.It was stated that they feel like their symptoms are worse than ever, with them having increased tremor and more difficulty walking now.The patient and their spouse believe that there is an issue with the new battery, causing the sudden decrease in therapy.There were no environmental factors that lead to the issue, and lead and therapy impedances were found to be normal, with the battery also having a normal level and on 100 percent of the time.The healthcare provider (hcp) increased the pulsewidth and lowered the patient's voltage which seemed to help with their tremor slowness and ambulation, and the patient is going to try the new settings for a while to see if their improvement lasts.It is unknown if the problem has resolved yet and the patient will see the hcp around (b)(6) 2017 to check, and mentioned that surgical intervention is planned with no scheduled date.The patient's indication for implant is parkinson's dual and movement disorders.See related regulatory report 3004209178-2016-27318.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that programming was done on (b)(6) 2017.It was reported that post programming, the patient¿s tremor improved significantly with adjustments made by increasing amplitude.It was reported that later that day the patient reported that tremor returned.It was noted that the healthcare professional (hcp) was making a change to the patient¿s medication routine to see if that would help hold tremor/facial dystonia longer.It was reported that the patient does not completely lose benefit, but does not feel as good as on the first initial programming.It was noted that the hcp did not think it was device related, but the patient did.It was stated there was no issue with impedances and that the hcp was going to send patient for a second opinion.

Manufacturer Narrative

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.

Event Description

Additional information was received.The battery was replaced on their right side today.The patient wants the device to be mailed in for an analysis.The patient felt that since the battery replacement in 2016, they haven't had the therapeutic benefit that they had from the previous implanted batteries.The patient understood it could be disease progression, but they wanted the battery to be analyzed.It was also noted the patient had some tremor control and no impedance issues.No further complications were reported as a result of this event.

• 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: 6210187
• MDR Text Key: 63412519
• Report Number: 3004209178-2016-27319
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2017
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2018
• Date Device Manufactured: 02/16/2016
• 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: 57 YR
• Patient Weight: 100