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

Model Number 37612

Device Problems Unstable (1667); 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  

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 (b)(6) and (b)(6) required their r-ipgs to be anchored to the muscle and fascia.Cases (b)(6) and (b)(6) 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 (b)(6), 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 that a (b)(6) woman with a history of parkinson's disease was having difficulties of charging their ins at 13 months post operation.They were only getting one or two coupling bars for coupling efficiency.An x-ray revealed the ins was upside down without any twisting or breakage of the extension wire.Manual manipulation failed to flip the ins so surgery was performed.They found that the anchoring wire had fallen and the ins was upside down.They re-implanted the ins and used two anchoring wires to attach it to the pectoralis fascia, where they experienced a complication free recovery.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

Manufacturer Narrative

Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

• 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: 13091148
• MDR Text Key: 288290891
• Report Number: 2182207-2021-02234
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SG
• 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: 71 YR
• Patient Sex: Female