MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Muscular Rigidity (1968); Pain (1994); Scarring (2061); Neck Pain (2433); Neck Stiffness (2434)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 15-nov-2021, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 11-nov-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported there was an increase in post-implant pain/neck pain.They are meeting with the patient on (b)(6) 2020 to evaluate.They will be running impedance tests and implantable neurostimulator (ins) check.The issue was not resolved.Additional information was received on 2020-feb-13 stating the patient had impedance tests run and impedances were all within normal range.The patient noted that she does not always have neck pain but more tightness.She also mentioned she was getting headaches on and off.The rep said that it was clear by looking at the patient that her extensions were tight.The right was visibly tighter than the left.When the patient turned her head to the left, the right extension became very pronounced.The patient thought it limited her neck mobility on that side.The cause of the pain/tightness was unknown but the patient said it had gotten gradually worse since stage 2 of her implant surgery.The patient tried botox injections and physical therapy to help with the neck pain/tightness but she had no relief after either.The hcp was considering doing more neck injections to fix the issue and the patient was also referred to a neurosurgeon for a surgical consult.The issue was not resolved.Additional information was received on 2020-mar-04 reporting that the patient had an upcoming appointment with the neurologist and had a neurosurgical consult scheduled with a neurosurgeon, but the date of the appointment was unknown.Additional information was received on 2020-apr-13 stating due to covid-19, no appointments were being planned and no additional information could be obtained.Additional information was received from a consumer on 2020-aug-14 reporting that since implant, they had thickening of the tissue around the leads.It was pulling both left and right and was causing really bad headaches/started getting really bad migraines.Botox did not help with the migraines, so they decided to implant the new therapy.The patient was implanted yesterday with a percept implantable neurostimulator (ins).They stated 3 other patients of a physician had the same issue with thickening tissue around the leads but no one has ever seen that before.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10417581
• MDR Text Key: 207160888
• Report Number: 3004209178-2020-14214
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• 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: 70 YR