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

Model Number 37601

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

Patient Problems Hemorrhage/Bleeding (1888); Irritation (1941); Undesired Nerve Stimulation (1980); Skin Discoloration (2074); Discomfort (2330); Neck Stiffness (2434); Electric Shock (2554)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3708640, serial#: (b)(4), implanted: (b)(6) 2016, product type: extension.Product id: 3708640, serial#: (b)(4), implanted: (b)(6) 2016, product type: extension.Other relevant device(s) are: product id: 3708640, serial/lot #:(b)(4), ubd: 28-jul-2020, udi#: (b)(4) ; product id: 3708640, serial/lot #: (b)(4), ubd: 12-jul-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for the treatment of movement disorders.The patient also reported that she did not know the ins would be as big as it was and the ins box was sticking out and bothering her.The patient state it was hideous, big, and she was a little person and had no flesh where they implanted it.The patient also stated the wires stuck out, were sore, and irritated her behind the ear because this was right where she wore glasses.The patient spoke to the nurse at the managing //hcps office and the nurses solution was to place a little bandage there which only helped for about 5 minutes.The patient also reported she had discoloration and it was a little darkened below the battery site.She told her health care professional (hcp) about this and he told her it was just "a little hemorrhage".No further complications were reported or anticipated.Additional information was received from the consumer.The caller reported her battery was too big for her.It stuck out and moved all over.It tugged and pulled an felt like her head was going to go into her neck.The caller noted her physician implanted the ins "under a muscle" but she thought it was actually on a nerve or something because if she touched the ins are, her whole side would jump.The caller stated the implant bothered her.The caller also reviewed her implanting health care professional (hcp) office told her to do neck exercises to minimize scar tissue.Her neurologist heard about this and said that she should not do this.The implanting physician stated they learned it at a seminar.The caller thought the previous ins was smaller.It never bothered her.The caller stated the hcp told her it was her fault because she was so thin/small.The caller was directed to follow up with the hcp to troubleshoot the ins location.The patient had an appointment on (b)(6) 2019.No further complications were reported or anticipated.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3708640, serial# (b)(4), implanted: (b)(6) 2016, product type: extension; product id: 3708640, serial# (b)(4), implanted: (b)(6) 2016, product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the tugging/pulling feeling and movement were not determined.Surgical intervention was discussed, but no intervention was planned at that moment.It was noted that the hcp was not the implanting surgery group.The issues were likely not resolved.The cause of the jumping when touching the ins was also not determined.Surgical intervention was offered, but not planned/scheduled.The resolution of the jumping issue was unknown.There were no further complications reported.

Manufacturer Narrative

The correct 'date received by mfr' for follow up number 001 is 2019-01-18.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: 8191790
• MDR Text Key: 131336636
• Report Number: 3004209178-2018-28280
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2019

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: 02/28/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 08/30/2018; 01/18/2019
• Supplement Dates FDA Received: 01/30/2019; 01/31/2019
• Date Device Manufactured: 09/08/2016
• 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 Age: 77 YR