MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Unstable (1667); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37612, serial#: unknown, product type: implantable neurostimulator.The main component of the system.Other relevant device(s) are: product id: 37612, serial/lot #: unknown.Please note that this device was used in an off-label manner as it was implanted for tourette's syndrome.One patient was male and one patient was female.This value is the average age of the patients reported in the article as one patient was (b)(6) and one patient was (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Hongyang li, daoqing su, yijie lai, xinmeng xu, chencheng zhang, bomin sun, dianyou li and yixin pan.Recharging difficulty with pulse generator after deep brain stimulation: a case series of five patients.Doi 10.3389/fnins.2021.705483.Background: deep brain stimulation (dbs) is a well-established treatment for a variety of movement disorders.Rechargeable cell technology was introduced to pulse generator more than 10 years ago and brought great benefits to patients.However, with the widespread use of rechargeable implanted pulse generators (r-ipgs), a new hardware complication, when charging the r-ipg has been difficult, was encountered.Objective: the aims of this study were to report five cases confronted with r-ipg charging difficulty postoperatively and to explore the predisposing factors and treatment strategies for this rare complication.Methods: we retrospectively reviewed our dbs patient database for those who were implanted with r-ipgs.From 2012, we identified a total of 1,226 patients, with five of them experiencing charging difficulties after surgery.Detailed patient profiles and clinical procedures were scrutinized and reviewed.Results: all the charging problems were resolved by reoperation.Cases 1 and 2 required their r-ipgs to be anchored to the muscle and fascia.Cases 3 and 4 had their r-ipgs inserted in the wrong orientation at the initial surgery, which was resolved by turning around the r-ipgs at the revision surgery.Case 5, in which we propose that the thick subcutaneous fat layer blocked the connection between the r-ipg and the recharger, required a second operation to reposition the r-ipg in a shallow layer underneath the skin.For all cases, the charging problems were resolved without reoccurrences to date.Conclusion: our case series indicates a novel hardware complication of dbs surgery, which had been rarely reported before.In this preliminary study, we describe several underlying causes of this complication and treatment methods.Reported events:  it was reported there was a (b)(6)-year old female with a long history of severe medication-refractory tourette syndrome that started experiencing difficulties with recharging their ins.When they attempted to use the charger located superficially on their ins one or two markers lit up, implying perfect coupling couldn't be achieved.An x-ray revealed the ins was upside down inside the chest pocket.During the 18 month postoperative meeting they had lost more than 15 kg of weight and admitted intentional manipulation of their ins.The doctors then tried to manually manipulate the ins back to its original spot, but they failed to do so.A revision surgery was done where it was noted that ins was found upside down in the chest pocket and needed to be anchored to the pectoralis fascia with 2-0 silk sutures and reduced the pocket size by stitching its inferior, medial, and lateral aspects.The postoperative period was uneventful and no charging difficulties had occurred since.  it was reported that there was a (b)(6) year old male with longstanding history of tourette's that began to experience difficulties charging their ins 3 years after implantation.They complained of extensive charging times and reduced charging efficiency.When they visited their hospital the second time they weight (b)(6) kg and had a body mass index of 33.4 g/m2 (30.0 is classified as obese).The ins was in good position on the x-ray, but a revision surgery was undertaken.During the operation they found that the thickness of the thoracic subcutaneous fat layer was approximately 2cm.The removed their ins from the subcutaneous pocket and achieved good connection between the charger and the ins.A shallower pocket 1 cm underneath the skin surface was created to accommodate the ins and charging capabilities were restored without complications.The patient's indication for use was tourette's syndrome.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13091118
• MDR Text Key: 288289996
• Report Number: 2182207-2021-02233
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2021
• 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: 28 YR