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

Model Number 37612

Device Problems High impedance (1291); Low impedance (2285); Delayed Charge Time (2586); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider via a manufacturing representative about a patient with an implantable neurostimulator (ins) for dystonia.It was reported that the patient was implanted for dystonic tremor in (b)(6) 2018.The patient is finding that it takes hours to charge, and they can never get up to a sufficient charge level as it is taking too long.The patient sometimes gets two white squares on efficiency.There were no symptoms reported.No further complications were reported or anticipated.Additional information was received from a health care provider (hcp).Device information and implant date received.It was stated that the patient has had trouble charging since implant of the device.The patient contacted their hcp in (b)(6) 2019 to report the issues charging and that they would have to charge in phases since they get pain in their back.It was stated that they have not have good symptom control since getting the new ins in (b)(6).Impedance measurements were taken and contacts 1+2, 1+3 and 2+3 were low at 100 ohms.Contacts c+8 was also high.The hcp did not know why it was taking so long to charge, and was wondering if the patient was not getting good contact or if they were losing efficiency during charging.The patient's settings were reprogrammed to see if they can get better symptom control.The patient will be reviewed again by their hcp in (b)(6) 2019.

Manufacturer Narrative

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

Event Description

Additional information reported the patient's next appointment with the neurosurgeon was scheduled for (b)(6) 2019.

Manufacturer Narrative

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

Event Description

Additional information was received.No troubleshooting had been performed.The programming was adjusted, which seemed to help, and the patient was receiving therapy.No further action was planned until the patient was seen by the neurosurgeon.

Manufacturer Narrative

Section 'device' information references the main component of the system and other applicable components are: product id neu_unknown_lead, lot# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a hcp.It was reported that after review one of the patient's leads was found to be not optimally placed.A lead revision will be performed.There are no further complaints regarding the efficiency of charging.

• 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: 8761358
• MDR Text Key: 150189234
• Report Number: 3004209178-2019-12960
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2019

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: 09/14/2019
• 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: 06/21/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 07/05/2019; 07/12/2019; 09/20/2019
• Supplement Dates FDA Received: 07/10/2019; 07/15/2019; 09/24/2019
• Date Device Manufactured: 10/22/2018
• 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